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  5. Inspection and Field Testing of Radiation-Emitting Electronic Products: Attachment B: Specific Instructions for Laser Product Inspections and Tests
  1. Device Advice: Comprehensive Regulatory Assistance

Inspection and Field Testing of Radiation-Emitting Electronic Products: Attachment B: Specific Instructions for Laser Product Inspections and Tests

Inspection and Field Testing of Radiation-Emitting Electronic Products: Attachment B: Specific Instructions for Laser Product Inspections and Tests

Background

The Laser Products Performance Standard (the standard), promulgated in August 1976, was designed to protect the public from unnecessary radiation hazards associated with the use of these products. The radiation emitted from these laser products can pose varying degrees of hazards depending upon the type, magnitude, and accessibility of the radiation and upon the particular functions or operations they perform. The standard was last amended in 1985. Since then, the CDRH has intended to harmonize the requirements of the standard with those of the international standard IEC 60825-1: 2001. As an interim step the CDRH published its Laser Notice 50 in 2001 stating that it would not object to compliance with specified requirements of the international standards in lieu of comparable requirements of the CDRH standard.

Specific Instructions

High-risk laser products and their manufacturers should be inspected or tested as a priority. Examples of high-risk laser products and manufacturers include:

  • Class IIIb and IV medical lasers (e.g. surgical)
  • Class IIIb and IV industrial lasers used in material processing
  • Class IIIb and IV lasers used in law enforcement or military applications
  • Manufacturers with known or suspected problems based on previous inspection, field tests or complaints
  • New manufacturers not yet inspected
  • Manufacturers introducing new technology to the US market
  • Manufacturers with a large potion of the US market share for any laser product. Class I low risk laser products, such as optical disk drives or laser printers, should not be inspected or tested.

Electro-optics specialists have been specifically trained in general EPRC requirements and also have specialized training in the laser product performance standards. EOS’s should perform these inspections and field tests, and may train additional field staff or accompany a medical device investigator to conduct joint EPRC/medical device inspections. If an EOS has training in both EPRC and QSIT inspections, a single EOS may conduct both portions of the inspection.

CDRH is responsible for review of laser manufacturer inspection and product field test observations and initiating administrative or regulatory follow-up.

References

Frequently Asked Questions about Lasers.

Performance Standard-Lasers and Products Incorporating Lasers
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=1040.10

Performance Standard-Specific Laser Products (Includes Display, Survey, and Medical Laser Products)
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=1040.11

Laser Compliance Guide

Reporting Guide-Radiation Safety Product Report for Laser Products
Reporting Guide-Radiation Safety Product Report for Laser Light Shows/Displays
Laser Quality Control Guide

Refer to the laser products main page for guidance documents and additional information.

Laser Product Codes

Translation of 2-Digit Code Product Name Product Code CFR Definition
Other Laser ProductsAutomotive Accessory, Automobile or Transport Vehicle, Laser95RDV1040.10A laser product or product containing a laser that is an automotive or other transport vehicle accessory.
Other Laser ProductsGeneral Purpose Laser Products, Non-Medical95RDW1040.10Product, laser, general, emit beam; A laser or product containing a laser that is intended for general purpose use with no medical claims.
Other Laser ProductsOther95RZZUnkA laser or product containing a laser for which its intended use is not previously defined.
Laser Light Show/Display ProductsLow-Power Laser Light Show Projector95RDZ1040.10;
1040.11
Product, laser, demo, projector, laser light show/display, Class IIIa/3R and lower; Laser projection system that incorporates a laser having a maximum radiation output of less than 5mw.
Laser Light Show/Display ProductsHigh-Power Laser Light Show Projector (Output > 5mW)95REA1040.10;
1040.11
Product, laser, demo, projector, laser light show/display, Class IIIb/IV/3B/4; Laser projection system that incorporates a laser having a maximum radiation output power greater than 5mw.
Laser Light Show/Display ProductsHigh-Power Laser Light Show95REB1040.10;
1040.11
Product, laser, demo, laser light show/display, Class IIIb/IV/3B/4; Laser light show or demonstration using laser projection equipment having an output that exceeds 5mW
Laser Light Show/Display ProductsLaser Video Projector95REC1040.10;
1040.11
Product, laser, demo, projector, display, video; A laser used in conjunction or incorporated in a video display system or projector.
Laser Light Show/Display ProductsLaser Advertising Display System95RED1040.10;
1040.11
Product, laser, demo, system, display, advertising
Laser Light Show/Display ProductsLaser Visual Display - Display Retinal Image, Non-Medical Display Product95REE1040.10;
1040.11
Product, laser, display, system, images, direct to retina
Laser Light Show/Display ProductsOther95RZZUnkOther laser products used in light shows or demonstrations that are not otherwise defined.
Medical Laser ProductsLaser, Ophthalmic86HQF1040.10;
1040.11
 
Medical Laser ProductsLaser Instrument, Surgical, Powered79GEX1040.10;
1040.11
 
Medical Laser ProductsLaser, Surgical, Gynecologic85HHR1040.10;
1040.11
 
Medical Laser ProductsLaser, ENT Microsurgical Carbon-Dioxide77EWG1040.10;
1040.11
 
Medical Laser ProductsPhotocoagulator and Accessories86HQB1040.10;
1040.11
 
Medical Laser ProductsLens, Surgical, Laser, Accessory, Ophthalmic Laser86LQJ1040.10;
1040.11
 
Medical Laser ProductsLaser, Neurosurgical84LKW1040.10;
1040.11
 
Medical Laser ProductsLaser, Neurosurgical, Argon84LLF1040.10;
1040.11
 
Medical Laser ProductsLaser, Neodymium: YAG, Pulmonary Surgery73LLO1040.10;
1040.11
 
Medical Laser ProductsLaser, Neodymium: YAG, for Gynecologic Use85LLW1040.10;
1040.11
 
Medical Laser ProductsLaser, Neodymium: YAG, Ophthalmic for Uses Other than Posterior Capsulotomy and Cutting Pupil86LXS1040.10;
1040.11
 
Medical Laser ProductsLaser, Neodymium: YAG, Ophthalmic for Uses Other than Posterior Capsulotomy86LOI1040.10;
1040.11
 
Medical Laser ProductsLaser, Neodymium: YAG, Optical, Pumped Parametric Oscillator86MVQ1040.10;
1040.11
 
Medical Laser ProductsLaser, Microsurgical Argon, for Use in Otology77LXR1040.10;
1040.11
 
Medical Laser ProductsLaser, Microsurgical Argon, for Uses Other Than Otology77LMS1040.10;
1040.11
 
Medical Laser ProductsLaser for Gastro-Urology Use78LNK1040.10;
1040.11
 
Medical Laser ProductsDevice, Angioplasty, Laser, Coronary74LPC1040.10;
1040.11
 
Medical Laser ProductsDevice, Laser Peripheral Angioplasty74LWX1040.10;
1040.11
 
Medical Laser ProductsCatheter, Coronary Laser Myoplasty74MGC1040.10;
1040.11
 
Medical Laser ProductsSystem, Laser, Transmyocardial Revascularization74MNO1040.10;
1040.11
 
Medical Laser ProductsInstrument, Visual Field, Laser86HPJ1040.10;
1040.11
 
Medical Laser ProductsLaser for Pain Therapy84LLP1040.10;
1040.11
 
Medical Laser ProductsLaser, System, Excimer86LZS1040.10;
1040.11
 
Medical Laser ProductsLaser, Dental76LYB1040.10;
1040.11
 
Medical Laser ProductsPhotodynamic Therapy (PDT)79MVF1040.10;
1040.11
 
Medical Laser ProductsPhotodynamic Therapy (PDT), Fiber Optic79MVG1040.10;
1040.11
 
Medical Laser ProductsLaser, Fluorescence Caries Detection76NBL1040.10;
1040.11
 
Medical Laser ProductsLaser for Wound Healing79LXU1040.10;
1040.11
 
Medical Laser ProductsOphthalmoscope, Laser Scanner86MYC1040.10;
1040.11
 
Medical Laser ProductsLaser, Phacolysis86MXO1040.10;
1040.11
 
Medical Laser ProductsCaries Detector, Laser, Light, Transmission76NTK1040.10;
1040.11
 
Medical Laser ProductsOther95RZZUnkA laser or laser product intended for medical treatment or other uses on humans, not previously defined.
Other Demonstration Laser ProductsLaser Science Education Products95REI1040.10;
1040.11
Product, laser, demo, education, illustrate science principles
Other Demonstration Laser ProductsOther95RZZUnkLaser products used for demonstrations that are not otherwise defined.
Toy, Novelty, Play Laser ProductsToy, Novelty, Play Laser Product95REJ1040.10;
1040.11
Product, laser, toy/novelty
Research, Scientific, Laboratory Laser ProductsResearch Laser, Scientific, Laboratory Laser Products95REK1040.10Product, laser, research/laboratory; A laser under development in and of itself. A laser used for conducting research during development of new data or to improve a process would not be considered a research laser although it is being used in research.
Research, Scientific, Laboratory Laser ProductsGuide-Star Laser System, Research, Scientific, Laboratory Laser Products95REL1040.10Product, laser, adaptive-optics telescope focusing accessory, generate artificial star; A laser used for alignment of optical telescopes.
Research, Scientific, Laboratory Laser ProductsSpectroscopy Instrument, Laser, Research, Scientific, Laboratory Laser Products95REM1040.10Product, laser, instrument, spectroscopy; An instrument incorporating a laser for spectroscopic testing or examination with no medical claims.
Research, Scientific, Laboratory Laser ProductsParticle-Size Measuring Instrument, Laser, Scientific, Laboratory Laser Products95REN1040.10Product, laser, instrument, particle size measurement; An instrument or system incorporating a laser for determining the size or number of particles of particles a test sample.
Research, Scientific, Laboratory Laser ProductsAnalytical Measuring and Detection, Research, Scientific, Laboratory Laser Products95REO1040.10Product, laser, instrument, analyze/detect chemical species
Research, Scientific, Laboratory Laser ProductsOther95RZZUnkLaser products used in scientific and laboratory applications that are not otherwise defined.
Surveying, Leveling, Alignment Laser ProductsSurveying Laser Product, Leveling, Alignment Laser Products95REP1040.10Product, laser, surveying, instrument, determine position by measurement of angles
Surveying, Leveling, Alignment Laser ProductsRanging (Geodimeter) Laser Products95REQ1040.10Product, laser, ranging, instrument, measure distance by time-of-flight
Surveying, Leveling, Alignment Laser ProductsAlignment Laser Product, Surveying, Leveling, Alignment Laser Products95RER1040.10;
1040.11
Product, laser, alignment, aid positioning or adjusting parts in relation to each other
Surveying, Leveling, Alignment Laser ProductsLaser Pointer, Surveying, Leveling, Alignment Laser Products95RES1040.10;
1040.11
Product, laser, pointer, indicate point of interest; A laser product intended specifically to define a spot or surface for drawing attention to a viewer.
Surveying, Leveling, Alignment Laser ProductsLaser Target Designator, Surveying, Leveling, Alignment Laser Products95RET1040.10Product, laser, target designator; An optical devices, using a visible beam of laser light that permits the alignment of a gun, cannon or rocket system with its target.
Surveying, Leveling, Alignment Laser ProductsLaser Aiming Product, Visible, Surveying, Leveling, Alignment Laser Products95REU1040.10;
1040.11
Product, laser, aiming, visible, attached to weapon; An optical devices, using a visible beam of laser light that permits the alignment of a gun, cannon or rocket system with its target
Surveying, Leveling, Alignment Laser ProductsLaser Aiming Product, Non-Visible, Surveying, Leveling, Alignment Laser Products95REV1040.10;
1040.11
Product, laser, aiming, infrared, attached to weapon, viewed with night-vision equipment; An optical devices, using an invisible beam of laser light that permits the alignment of a gun, cannon or rocket system with its target.
Surveying, Leveling, Alignment Laser ProductsOther95RZZUnkOther laser products used for surveying, leveling and alignment that are not otherwise defined.
Safety, Security, Surveillance Laser ProductsIR Laser Illuminator with Alignment Aid/Night Vision System, Safety, Security, Surveillance Laser Products95REW1040.10;
1040.11
Product, laser, infrared, illuminator with alignment aid, viewed through night-vision equipment
Safety, Security, Surveillance Laser ProductsIR Laser Illuminator Only/Night Vision System, Safety, Security, Surveillance Laser Products95REX1040.10Product, laser, infrared, illuminator only, viewed through night-vision equipment
Safety, Security, Surveillance Laser ProductsCollision-Avoidance Laser System, Safety, Security, Surveillance Laser Products95REY1040.10Product, laser, infrared, collision-avoidance system
Safety, Security, Surveillance Laser ProductsLaser Traffic Signal, Safety, Security, Surveillance Laser Products95REZ1040.10Product, laser, traffic signal/control
Safety, Security, Surveillance Laser ProductsLaser Automotive Lighting & Signals, Safety, Security, Surveillance Laser Products95RFA1040.10Product, laser, automotive, lighting/signals
Safety, Security, Surveillance Laser ProductsIR Laser Intrusion Detection/Security System, Safety, Security, Surveillance Laser Products95RFB1040.10Product, laser, infrared, intrusion detecting, security system
Safety, Security, Surveillance Laser ProductsLaser Radar (Lidar) or Speed Measurement, Safety, Security, Surveillance Laser Products95RFC1040.10Product, laser, infrared, Doppler or time-of-flight speed measurement
Safety, Security, Surveillance Laser ProductsOther95RZZUnkLaser products used in safety, security, surveillance applications not otherwise defined
Safety, Security, Surveillance Laser ProductsLaser Weapon (Military or Police), Safety, Security, Surveillance Laser Products95RFD1040.10Product, laser, weapon (military/police)
Material Processing Laser ProductsLaser Cutter, Material Processing Laser Products95RFE1040.10A high power laser intended to cut or drill a variety of materials in an industrial or commercial environment.
Material Processing Laser ProductsLaser Welder, Material Processing Laser Products95RFF1040.10A high power laser intended to weld (join) materials in an industrial or commercial environment.
Material Processing Laser ProductsMicroelectronic Mask or Chip Checking/Repair, Material Processing Laser Products95RFG1040.10A laser intended to inspect and/or repair microelectronic components in an industrial or commercial environment.
Material Processing Laser ProductsUV Curing, Material Processing Laser Products95RFH1040.10An ultraviolet wavelength laser used to illuminate a material of a certain composition such that the laser "cures" or causes a chemical reaction to change the material in a desired fashion with no medical claims. Typical materials are adhesives, plastics, potting compounds, etc.
Material Processing Laser ProductsPrint Industry Plate Maker, Material Processing Laser Products95RFI1040.10A laser intended to etch, engrave or otherwise create printer's plates used in an industrial or commercial environment.
Material Processing Laser ProductsProcess Control, Material Processing Laser Products95RFJ1040.10A laser used for inspection, counting, or other application intended to monitor a part of the manufacturing process in an industrial or commercial environment. Often incorporated in an automated process system.
Material Processing Laser ProductsLaser Vision, Material Processing95RFK1040.10A laser used for positioning, focusing, inspection, counting, or other application in an industrial or commercial environment. Often incorporated in an automated assembly line system.
Material Processing Laser ProductsLaser Micrometer, Material Processing95RFL1040.10A laser used in high precision dimensional measurements in materials processing.
Material Processing Laser ProductsLaser-Based Material Positioning System95RFM1040.10A laser used in precision positioning of materials in manufacturing in an industrial or commercial environment.
Material Processing Laser ProductsOther95RZZUnkA laser used in materials processing not otherwise defined.
Material Processing Laser ProductsGeneral Industrial Use Material Processing Laser Products95RZN1040.10A laser used in industrial manufacturing or materials processing not otherwise defined.
Data Measurement, Transmit, Control Laser ProductsFiber Optic Communication and Data Transfer, Laser95RFN1040.10A laser used in fiber optic communications to transmit data and information.
Data Measurement, Transmit, Control Laser ProductsIR Free-Space Data Transmit/Control, Laser95RFO1040.10A laser used in free space (open air) communications to transmit data and information.
Data Measurement, Transmit, Control Laser ProductsRemote Controller, Laser, Data Measurement, Transmit95RFP1040.10A laser used to transmit signals and/or information in order to operate equipment or machinery remotely.
Data Measurement, Transmit, Control Laser ProductsInterferometric Position Measuring Product, Laser95RFQ1040.10A laser used as an interferometer for high precision positioning and/or measurements.
Data Measurement, Transmit, Control Laser ProductsProduct Incorporating Certified Class 1 Laser Data Measurement, Transmit, Control95RFR1040.10A data measurement, data transmission, or remote control product that incorporates a certified Class 1 laser.
Data Measurement, Transmit, Control Laser ProductsOther95RZZUnkA data measurement, data transmission, or remote control product that incorporates a laser other than a certified Class 1 laser.
Utility/Peripheral Laser ProductsReprographics, Laser, Utility/Peripheral Laser Products95RFS1040.10A reprographics machine that incorporates a laser utilized to expose internal sensitive components or materials for photocopying text and graphics.
Utility/Peripheral Laser ProductsLaser Printer, Utility/Peripheral Laser Products95RFT1040.10A printing machine that incorporates a laser utilized in printing images on paper with no medical claims.
Utility/Peripheral Laser ProductsLaser FAX Machine, Utility/Peripheral Laser Products95RFU1040.10A printing machine that incorporates a laser utilized in printing facsimiles of images on paper.
Utility/Peripheral Laser ProductsCD, CD-ROM Player, Laser Utility/Peripheral Laser Products95RFV1040.10A CD or CD-ROM player that utilizes a laser to read data on the compact disc.
Utility/Peripheral Laser ProductsDVD, DVD-ROM Player, Laser Utility/Peripheral Laser Products95RFW1040.10A DVD or DVD-ROM player that utilizes a laser to read data on the digitally recorded video disc.
Utility/Peripheral Laser ProductsCD-R, CD-RW Recorder, Utility/Peripheral Laser Products95RFX1040.10A CD-R or CD-RW recorder machine that utilizes a laser to read and/or write data on the compact disc.
Utility/Peripheral Laser ProductsDVD-R, DVD+R, DVD-RAM, DVD+RW, DVD-RW Recorder, Utility/Peripheral Laser Products95RFY1040.10A DVD recorder machine that utilizes a laser to read and write or read, write, and erase data on a digitally recorded video disc in any of the data formats: DVD-R, DVD+R, DVD-RAM, DVD-RW, or DVD+RW.
Utility/Peripheral Laser ProductsUPC Reader (Bar Code Reader), Utility/Peripheral Laser Products95RFZ1040.10A laser used to scan across a bar code to identify the product. Bar code readers can be hand-held accessories, under-counter components incorporated in store check-out systems, or laser scanner systems incorporated in assembly lines used for identification and inventory purposes in manufacturing facilities, warehouses and storage facilities, or other consumer, industrial, health care, or commercial locations.
Utility/Peripheral Laser ProductsHome/Office Machine Incorporating Utility/Peripheral Laser95RZP1040.10A laser utilized in the home or office environment not otherwise defined.
Utility/Peripheral Laser ProductsProduct Incorporating Certified Class 1 Data Utility/Peripheral Laser Products95RGA1040.10A utility/peripheral laser product that incorporates a certified Class 1 laser.
Utility/Peripheral Laser ProductsOther95RZZUnkA utility/peripheral laser product that incorporates a laser other than a certified Class 1 laser.
In Vitro and Other Medical Laser ProductsVeterinary Laser, In Vitro and Other Medical Laser Products95RGB1040.10;
1040.11
A laser used for treatment of animals other than human
In Vitro and Other Medical Laser ProductsSeparator, Automated, Blood Cell, Diagnostic81GKT1040.10 
In Vitro and Other Medical Laser ProductsAutomated Differential Cell Counter81GKZ1040.10 
In Vitro and Other Medical Laser ProductsCell Particle Counter (Automated)81GKL1040.10 
In Vitro and Other Medical Laser ProductsUrine Particle Counter88LKM1040.10 
In Vitro and Other Medical Laser ProductsSystem, Separation, Hematopoietic Stem Cell81MZK1040.10 
In Vitro and Other Medical Laser ProductsTest, Urea (Breath or Blood) for H. Pylori Test83MSQ1040.10 
In Vitro and Other Medical Laser ProductsMultipurpose System for In-vitro Coagulation81JPA1040.10 
In Vitro and Other Medical Laser ProductsSystem, Laser Assisted Hatching85MRX1040.10;
1040.11
 
In Vitro and Other Medical Laser ProductsSorter, Cell81KEX1040.10 
In Vitro and Other Medical Laser ProductsSeparator, Semi-Automated, Blood Component81MYY1040.10 
In Vitro and Other Medical Laser ProductsOther95RZZUnkA laser used for in vitro applications or other medical applications that do not expose patients to the laser radiation.
Positioning Medical Laser ProductsX-Ray Field Indicator Light (Laser), Positioning Medical Laser Products95RGC1020.30;
1040.10;
1040.11
A laser incorporated in a diagnostic x-ray system that is irradiated onto the film screen area indicating the x-radiation area. The beam is usually scanned to show a rectangular region for patient placement.
Positioning Medical Laser ProductsMonitor, Patient Position, Light Beam90IWE1040.10;
1040.11
 
Positioning Medical Laser ProductsPositioning Medical Laser Product95RZS1040.10;
1040.11
A laser used for positioning in medical applications not otherwise defined.

Classification of Non-compliant Items

 

Performance requirements
1040.10(d)Classified in higher classMinor, ConcernClass B, C
1040.10(d)Classified in lower classMajorClass A
1040.10(f)(1)Protective housing allows unnecessary body access to Class IV or high IIIb radiationMajorClass A
1040.10(f)(1)Protective housing allows unnecessary straight line access to interior Class IV or high IIIb radiation
With high risk of exposure (IV or IIIb product)
With low risk of exposure (IV or IIIb product)
With any risk of exposure (I, IIa, II, or IIIa product)
Major
Minor
Major
Class A
Class B
Class A
1040.10(f)(1)Protective housing allows unnecessary body access to low Class IIIb or IIIa radiation
In a Class IV or IIIb product
In a Class I, IIa, II, or IIIa product
Minor
Major
Class B
Class A
1040.10(f)(1)Protective housing allows necessary body access to Class IIIa or IIIa radiation
In a Class IV or IIIb product
In a Class I, IIa, II, or IIIa product
Concern
Minor
Class C
Class B
1040.10(f)(1)Protective housing allows unnecessary body access to Class II radiation
In a Class II product
In a Class I product
Concern
Minor
Class C Class B
1040.10(f)(2)Safety interlocks absent when requiredMajorClass A
1040.10(f)(2)Single safety interlock when redundant requiredMajorClass A
1040.10(f)(2)Single component with multiple contacts when redundant requiredMinorClass B
1040.10(f)(2)Defeatable safety interlocks lacks indicationMinorClass B
1040.10(f)(2)Defeatable safety interlocks fails to prevent replacement of protective housing during defeatMinorClass B
1040.10(f)(3)No remote interlock connectorMajorClass A
1040.10(f)(4)No key controlMajorClass A
1040.10(f)(4)Key control removable when onMajorClass A
1040.10(f)(5)No emission indicatorMajorClass A
1040.10(f)(5)No delay preceding radiation emissionMinorClass B
1040.10(f)(5)Shorter delay than requiredMinorClass B
1040.10(f)(5)Remote control lacks emission indicatorMajorClass A
1040.10(f)(6)Beam attenuator without approvable alternateMajorClass A
1040.10(f)(6)Beam attenuator with approvable alternateConcernClass C
1040.10(f)(8)Viewing optics
Hazardous
Non-hazardous for viewing period
Major ConcernClass A
Class C
1040.10(f)(9)No scanning guardsMajorClass A
1040.10(f)(10No manual resetMajorClass A
1040.10(g)(1), (2), and (3)Warning logotype
None
Classification too low
Classification too high
Major
Major
Minor, Concern
Class B
Class B
Class B
1040.10(g)(4)Warning logotype output informationMinorClass B
1040.10(g)(5)No aperture labelMinorClass B
1040.10(g)(5)Aperture label not in close proximity to apertureMinorClass B
1040.10(g)(5)Aperture label wording incorrectConcernClass C
1040.10(g)(6), (7)No protective housing labelsMinorClass B
1040.10(g)(6), (7)Protective housing placement inappropriateMinorClass B
1040.10(g)(6), (7)Protective housing wording wrongConcernClass C
1040.10(g)(8)Invisible radiation warning on labelsMinorClass B
1040.10(g)(9), (10)Label positioning and legibilityMinorClass B
1040.10(h)(1)User instructions
(i) Promoting unsafe practices
Inadequate instructions to avoid exposure
(ii) Inadequate radiometric specifications
(iii) Inadequate reproductions and locations
(iv) Inadequate listing of controls
Inadequate caution statement
Major
Minor
Minor
Minor
Minor
Concern
Class A
Class B
Class B
Class B
Class B
Class C
1040.10(h)(2)(i)Reproduction of warning logotype not in catalogsMinorClass B
1040.10(h)(2)(ii)Service information inadequateMinorClass B
Specific product requirements
1040.11(a)(1)Means to measure medical laser output
None
Inaccurate
Major
Major
Class A
Class A
1040.11(a)(2)Inadequate calibration procedure/scheduleMajorClass A
1040.11(a)(3)Aperture labelMinorClass B
1040.11(b)Excessive output on surveying lasersMajorClass A
1040.11(c)No variance for demonstration Class IIIb or Class IV lasersMajorClass A

Sample Laser Product Inspection and Field Test Checklist

LASER PRODUCT TEST RECORD

MANUFACTURER____________________ CLASS____________

MODEL_______________________ SERIAL NUMBER_______

Status of Unit Examined (Circle one): Prototype/Production unit

Status of Assembly (circle one): Complete/Incomplete

Manufactured Date:_________________________

A. Product Description: (Include basic configuration and size of product, reference to photos and/or
diagrams, basic functions to be performed during operation and during maintenance.)

_________________________________________________________________

_________________________________________________________________

_________________________________________________________________

_________________________________________________________________

_________________________________________________________________

_________________________________________________________________

_________________________________________________________________

_________________________________________________________________

Product Report: Has the product been reported to CDRH?

Yes_________ No_________

If yes, what is the Accession Number? _____________________________

Summary of Product Evaluation:

_________________________________________________________________

_________________________________________________________________

_________________________________________________________________

_________________________________________________________________

_________________________________________________________________

_________________________________________________________________

_________________________________________________________________

_________________________________________________________________

_________________________________________________________________

_________________________________________________________________

_________________________________________________________________

_________________________________________________________________

_________________________________________________________________

_________________________________________________________________

_________________________________________________________________

_________________________________________________________________

C. Certification/Identification Requirements. If possible, obtain a sample of each required label and attach it to this report. Otherwise, quote pertinent information, especially any noncompliant items.

1. Certification label (1010.2)

a. Is the label permanently affixed? Yes___ No___ ND___ NA___

b. Is the Label readily viewable? Yes___ No___ ND___ NA___

Location:______________________

c. Is the label properly stated? Yes___ No___ ND___ NA___

(Note: Products under variance require modified certification labels 1010.4(d))

d. Remarks: ________________________________________________

__________________________________________________________

2. Identification label (1010.3)

a. Is the label permanently affixed? Yes___ No___ ND___ NA___

b. Is the label readily viewable? Yes___ No___ ND___ NA___

Location: _______________________

c. Does the label contain the full name and address?

Yes___ No___ ND___ NA___

d. Does the label contain the place of manufacture (in full or in code)?
Yes___ No___ ND___ NA___

e. If coded, has CDRH been provided the code?
Yes___ No___ ND___ NA___

f. Are the month and year of manufacture stated in full?*

Yes___ No___ ND___ NA___

Month and year: __________________________

g. Remarks:____________________________________________________

____________________________________________________________

*Note: Serialization is acceptable in lieu of month and year for consumer electronic products.

D. Special Purpose Products (1040.11)

1. Is the product a medical laser product?

Yes___ No___ ND___ NA___

Note: In inspecting manufacturers of not only medical laser products but also laser products that are medical devices, verify compliance with other applicable requirements including but not limited to current registration and listing, 510k market clearances, device master record or quality system, current complaint and service records, etc.

a. Does the product include a means of measurement of levels of radiation intended for irradiation of the human body?

Yes___ No___ ND___ NA___

b. How is this accomplished? Measure beam prior to delivery system and determine output levels via calibration constant _________;
Measure output of delivery system ___________;
Other ___________.

c. Indication: power ________; energy________; time _______.

d. Type of indicator: energy/power select switch ___; "Test shot" display (remains constant until next best shot) ___; Real time display (displays level at all times) ___; Other ___.

e. If test shot is available only at initiation of procedure or if a select switch is used, does the product have an internal monitoring system capable of maintaining output levels to within ± 20% of displayed value?
Yes ___ No___

f. Is display analog ____; or digital ____? If digital, are there sufficient significant digits to allow ± 20% accuracy? Yes ___ No ___

g. Is the total measurement error within ± 20% (see Attachment G) Yes___ No___ ND___ NA___

h. Is there a laser aiming beam? Yes ___ No ___. Is there a means to measure the level of the aiming beam if the product is ophthalmic and the aiming beam may exceed 1 mW or if the product is not ophthalmic but the aiming beam may exceed 5 mW?
Yes ___ No ___

i. Remarks: _____________________________________________________

_____________________________________________________________

2. Is the product a surveying, leveling, and alignment product?

Yes___ No___ ND___ NA___

a. Is access prevented for wavelengths of 400 nm to 710 nm to radiation power in excess of 5.0 mW for any duration greater than 3.8 x 10-4 seconds?

b. Is access prevented to radiation levels in excess of Class I limits for any other combination of emission Duration and wave length range?

Yes___ No___ ND___ NA___

c. Remarks: ____________________________________________________

____________________________________________________________

3. Is the product a demonstration laser product?
Yes___ No___ ND___ NA___

a. Does the product prevent human access to radiation in excess of the Class IIIa (3R) limit?
Yes___ No___ ND___ NA___

b. Remarks: ____________________________________________________

____________________________________________________________

E. Label Requirements. See instruction in paragraph B.

1. Warning logotypes* (1040.10(g)(1),(2),(3),(4),(5),(9), and (10)

a. Is the logotype the correct logotype?
Yes___ No___ ND___ NA___

b. Is the label properly worded for its class designation?

Yes___ No___ ND___ NA___

c. Does the label have the proper color?

Yes___ No___ ND___ NA___

d. Is the output information present and correct?

(Maximum output stated ________.) Yes___ No___ ND___ NA___

e. Is the media or wavelength information present and correct?

Yes___ No___ ND___ NA___

f. Is the label permanently affixed and clearly visible during operation, maintenance, and
service?
Yes___ No___ ND___ NA___

g. Is the label positioned so as to make exposure unnecessary during reading?
Yes___ No___ ND___ NA___
Location: ____________________

h. Does the label include a warning for "invisible" or "invisible and/or visible" radiation?
Yes___ No___ ND___ NA___

i. Remarks: __________________________________________________________

__________________________________________________________________

__________________________________________________________________

Note: Warning labels in accordance with IEC 60825-1 including product classification are acceptable.

2. Aperture label (for Classes II, IIIa, IIIb, IV, 3R, 3B and 4) 1040.10(g)(5),(8),(9), and (10)

a. Is a label present and in proximity to each aperture?

Yes___ No___ ND___ NA___

b. Is the label properly worded? Yes___ No___ ND___ NA___

c. Is the label permanently affixed and clearly visible?

Yes___ No___ ND___ NA___

d. Is the label positioned so as to make exposure unnecessary during reading?
Yes___ No___ ND___ NA___

(Location: ______________)

e. Does the label include a warning for "invisible" or "invisible and/or visible" radiation?
Yes___ No___ ND___ NA___

f. Remarks: __________________________________________________________

__________________________________________________________________

__________________________________________________________________

3. Noninterlocked protective housing label (1040.10(g)(6),(8),(9), and (10)

a. Are the labels on or near all appropriate panels or covers which are removed for operation, maintenance, or service?

Yes___ No___ ND___ NA___

b. Are all labels visible prior to removal of such portions of the protective housing?
Yes___ No___ ND___ NA___

c. Are all labels visible after opening?
Yes___ No___ ND___ NA___

d. Are all labels correctly worded? Yes___ No___ ND___ NA___

e. Are all labels permanently affixed and clearly visible?

Yes___ No___ ND___ NA___

f. Do all labels contain a warning for "invisible" or "invisible and/or visible" radiation? Yes___ No___ ND___ NA___

g. Remarks: __________________________________________________________

__________________________________________________________________

__________________________________________________________________

4. Defeatably interlocked housing labels 1040.l0(g)(7),(8),(9), and (10)

a. Are labels provided for each defeatably interlocked panel or cover which is removed for operation, maintenance, or service?

Yes___ No___ ND___ NA___

b. Are all labels visible prior to interlock defeat?

Yes___ No___ ND___ NA___

c. Are all labels visible during interlock defeat?

Yes___ No___ ND___ NA___

d. Are all labels correctly worded?

Yes___ No___ ND___ NA___

e. Are all labels permanently affixed and clearly visible?

Yes___ No___ ND___ NA___

f. Do all labels contain a warning for "invisible" or invisible and/or visible" radiation?
Yes___ No___ ND___ NA___

g. Remarks: _____________________________________________________

_____________________________________________________________

F. Performance Requirements (1040.l0(f)):

1. Protective Housing (1040.l0(f)(l))

a. Does the housing prevent access at all times to laser radiation above Class I not necessary for operation of the product?

Yes___ No___ ND___ NA___

b. Does the housing prevent access at all times to collateral optical radiation above Class I not necessary for operation of the product?
Yes___ No___ ND___ NA___

c. Has x-radiation been evaluated?
Yes___ No___ ND___ NA___

d. Does the housing prevent access to x-radiation levels in excess of 0.5 mR/hr at all times during operation of the product?

Yes___ No___ ND___ NA___

e. Remarks: _____________________________________________________

_____________________________________________________________

2. Safety Interlocks (1040.10(f)(2)) (Complete for each interlock. Identify the portion of
removable or displaceable housing and interlock described.)

a. Do operation or maintenance functions require moving portions of the housing which could allow access to radiation?

Yes___ No___ ND___ NA___

Describe: _____________________________________________________

_____________________________________________________________

b. Class of radiation to which access could be gained?
Class ______.

c. Is a fail safe or multiple interlock required (including 1040.l(f)(2)(iii)?

Yes___ No___ ND___ NA___

Where? ______________________________________________________

_____________________________________________________________

d. Are safety interlock(s) present? where?_______________

1. TYPE: Microswitch____; Mercury switch____;
male-female plug____; mechanical shutter____; other____.

Describe: _____________________________________________

e. Method of limiting access: directly interrupts primary laser power____; interrupts primary laser power through relay, contactor, switching tube or transistor____; spoils the cavity____; shutter beam via solenoid____; other____.

f. Is there a multiple or fail safe interlock on each housing for which an interlock is required?

Yes___ No___ ND___ NA___

g. Is the interlock defeatable? Yes___ No___ ND___ NA___

h. Is there an indication of defeat? Yes___ No___ ND___ NA___

Describe: _______________________________________________________

i. Does the interlock preclude replacement of the housing while the interlock is defeated?
Yes___ No___ ND___ NA___

j. Are non-safety interlocks present? Where?_____________

Yes___ No___ ND___ NA___

k. Remarks: _________________________________________________

_________________________________________________________

3. Remote Interlock Connector (1040.l0(f)(3), Class IIIb or IV systems only)

a. Is a remote control connector present?

Yes___ No___ ND___ NA___

b. Type? Describe: ________________________________________

c. Is the voltage across the connector less than 130 volts RMS?

Yes___ No___ ND___ NA___

d. Is the access to laser and collateral radiation prevented when the terminals are not joined?
Yes___ No___ ND___ NA___

e. Method of operation: Directly interrupts laser power____; interrupts laser power through relay, etc.____; shutters beam or interrupts cavity____.

f. Does the emission delay reactivate when the remote control circuit is interrupted?
Yes___ No___ ND___ NA___

g. Must the emission be manually restarted following interruption via the remote interlock connector?

Yes___ No___ ND___ NA___

h. Remarks: ____________________________________________________

____________________________________________________________

4. Key Control (1040.10(f)(4), Class IIIb, IV, 3B, or 4 systems only)

a. Is a key control present? Yes___ No___ ND___ NA___

Describe: ___________________________________________________

_____________________________________________________________

b. Is a key removable in the "on" position?

Yes___ No___ ND___ NA___

c. Is operation prevented when the key is removed?

Yes___ No___ ND___ NA___

d. How? ____________________________________________________

____________________________________________________________

e. Remarks: _________________________________________________

____________________________________________________________

5. Beam Attenuator (1040.l0(f)(6), Class IIIb, IV, 3B or 4 systems only)

a. Is a beam attenuator present? Yes___ No___ ND___ NA___

b. Type: mechanically operated shutter____; electrically operated____; aperture cap or cover____; other____.

Describe: ___________________________________________________

____________________________________________________________

c. Is the attenuator permanently attached?

Yes___ No___ ND___ NA___

d. Does the attenuator prevent access by any part of the body to radiation in excess of Class I limits?

Yes___ No___ ND___ NA___

e. If there is no beam attenuator, has the manufacturer requested and obtained approval of an alternate means of safety?

Yes___ No___ ND___ NA___

f. Remarks: _________________________________________________

_____________________________________________________________

6. Emission Indicator (1040.10(f)(5), Class, IIIb, IV, 3B or 4 Systems only)

a. Is an emission indicator present on the laser product?

Yes___ No___ ND___ NA___

Where? ________________________________________________

b. Type: tungsten lamp(s)____; neon lamp(s)____; LED(s)____; other____.

Describe: _________________________________________________

_______________________________________________________

c. If the indicator is visible, is it visible through the protective eyewear that is normally supplied or recommended?

Yes___ No___ ND___ NA___

d. Can the indicator be viewed without exposure to radiation in excess of Class I limits?

Yes___ No___ ND___ NA___

e. Is there a delay between an indication of emission and the beginning of emission?
Yes___ No___ ND___ NA___

f. How is emission delay achieved? Thermal relay___; inherent in the lasing process___; delay circuit___; other___.

Describe: ________________________________________________

_________________________________________________________

g. Length of delay? ____________________

h. Is the power source or operation control separable from the laser by greater than 2 meters when assembled for use?

Yes___ No___ ND___ NA___

i. If separated greater than 2 meters, is an emission indicator present on the energy source or controller?
Yes___ No___ ND___ NA___

Where? _____________________________________________________

j. Type: Tungsten lamp(s)___; neon lamp(s)___; LED(s)___; bell or buzzer___; meter or display___; mechanical flag___; other___.

Describe: ______________________________________________

______________________________________________________

k. Is there a delay between an indication of emission and the beginning of emission?
Yes___ No___ ND___ NA___

l. How is emission delay achieved? Thermal relay___; inherent in the lasing process___; delay circuit___; other___.

Describe: ______________________________________________

______________________________________________________

m. Length of delay? ____________________________________________

n. Remarks: __________________________________________________

____________________________________________________________

____________________________________________________________

6. Location of Controls (1040.10(f)(7))

a. Are the controls located so that exposure is unnecessary for operation or adjustments?
Yes___ No___ ND___ NA___

b. Remarks: __________________________________________________

____________________________________________________________

____________________________________________________________

7. Viewing optics (1040.l0(f)(8))

a. Are viewing optics or viewports present?

Yes___ No___ ND___ NA___

b. Type: microscope___; telescope___; viewport___; display screen___; other___.

Describe: ___________________________________________________

____________________________________________________________

____________________________________________________________

c. Where? ___________________________________________________

____________________________________________________________

d. Do the viewing optics attenuate radiation at all times during operation or maintenance to levels less than Class I limits?

Yes___ No___ ND___ NA___

e. Do the viewing optics employ a shutter or variable attenuator?

Yes___ No___ ND___ NA___

f. Upon failure of the shutter of the variable attenuator is access to radiation levels greater than the Class I limits prevented?
Yes___ No___ ND___ NA___

g. Remarks: _________________________________________________

____________________________________________________________

____________________________________________________________

8. Scanning Safeguard (1040.10(f)(9))

a. Is the radiation emitted by the product scanned?

Yes___ No___ ND___ NA___

b. Is the classification of the product based on the level of scanned radiation?
Yes___ No___ ND___ NA___

c. In the event of scan failure, is human access to laser radiation in excess of the product class prevented?

Yes___ No___ ND___ NA___

d. Remarks: _________________________________________________

_____________________________________________________________

9. Manual Reset Mechanism (1040.l0(f)(l0) Class IV laser systems)

Describe the operation of the Manual Reset. ___________________

____________________________________________________________

How is it achieved? (latching relay, etc.) ________________

____________________________________________________________

10. Removable laser system (1040.10(c)(2))

a. Does the product incorporate a laser system?

Yes___ No___ ND___ NA___

b. Is the laser system removable?
Yes___ No___ ND___ NA___

c. If removable, is the laser system independently certified?

Yes___ No___ ND___ NA___

d. If not removable, specify how removability is prevented: hard wiring___; modified connector___; assembled internally from components___; other (specify). __________________________

e. Remarks: __________________________________________________

____________________________________________________________

____________________________________________________________

G. Laser Product Measurements

Model # ________________________ Serial # _______________________

Manufacturer's Claimed Classification: ___________________________________

Brief description of product: ___________________________________________

___________________________________________________________________

___________________________________________________________________

Test Instrument(s) Used: _______________________________________________

___________________________________________________________________

Circle radiometric quantity tested and specify units below (Radiance (W cm-2 sr-1), Radiant Energy (J), Power (W), etc.)

Measurement No.Wavelength (nm)Instrument reading, R (units ________)Calibration factor, K (units ________)Corrected value, R*K (units ________)
     
     
     
     
     
     
     
     

Calculations (as needed):

__________________________________________________________________

__________________________________________________________________

________________________________________________________________________

________________________________________________________________________

________________________________________________________________________

________________________________________________________________________

H. Results of FDA measurements: ______________________________________________

________________________________________________________________________

________________________________________________________________________

________________________________________________________________________

________________________________________________________________________

________________________________________________________________________

________________________________________________________________________

________________________________________________________________________

________________________________________________________________________

________________________________________________________________________

I. Compliance with other requirements (e.g., conditions of a variance, labeling for medical devices, etc.)

________________________________________________________________________

________________________________________________________________________

________________________________________________________________________

________________________________________________________________________

________________________________________________________________________

________________________________________________________________________

________________________________________________________________________

________________________________________________________________________

________________________________________________________________________

J. Information requirements (Directions: Complete this section only if the information and requirements are reviewed during the inspection).

1. User Information (1040.l0(h)(l))

a. Does the manual contain adequate instructions for assembly,
operation, and maintenance? Yes___ No___ ND___ NA___

b. Does it contain clear warnings to avoid exposure?

Yes___ No___ ND___ NA___

c. Does it contain a statement of output parameters?

Yes___ No___ ND___ NA___

d. Does it contain legible reproductions of all labels and hazard warnings?
Yes___ No___ ND___ NA___

e. Does it include the corresponding position of each label on the product?
Yes___ No___ ND___ NA___

f. Does it contain listing of controls, adjustments, and procedures for operation and maintenance?
Yes___ No___ ND___ NA___

g. Does it contain a schedule of maintenance?

Yes___ No___ ND___ NA___

h. Does it contain the "Caution - use of controls..." warning?

Yes___ No___ ND___ NA___

i. Does it contain a compatibility statement (laser source or laser system not supplied with the product?

Yes___ No___ ND___ NA___

j. Does it contain a calibration schedule (medical laser product)?
Yes___ No___ ND___ NA___

k. Does it include a warning not to point the laser radiation at the audience (especially Class IIIa demonstration laser products)?
Yes___ No___ ND___ NA___

l. Does it include information to determine nominal hazard zone(class IV multi-axis workstations)?
Yes___ No___ ND___ NA___

m. Remarks: __________________________________________________________

__________________________________________________________________

__________________________________________________________________

2. Purchasing Information (1040.10(h)(2))

a. Are legible reproductions of the logotype required to be affixed to the product (including information required for positions 1, 2, and 3) contained in catalogues, specification sheets, and descriptive brochures?
Yes___ No___ ND___ NA___

3. Servicing Information (1040.l0(h)(2))

a. Are adequate instructions for service adjustments and service procedures available?
Yes___ No___ ND___ NA___

b. Are clear warnings and precautions to avoid possible exposure included?
Yes___ No___ ND___ NA___

c. Is a schedule of maintenance necessary to keep the product in compliance included?
Yes___ No___ ND___ NA___

d. Are controls and procedures which would he used by reasons other than the manufacturer or his agent to increase accessible emission levels listed?
Yes___ No___ ND___ NA___

e. Is a clear description of the locations of displaceable portions of the protective housing provided?
Yes___ No___ ND___ NA___

f. Do these instructions provide legible reproductions of required labels and hazard warnings?
Yes___ No___ ND___ NA___

g. Do these instructions include protective procedures for service personnel?
Yes___ No___ ND___ NA___

h. Remarks: __________________________________________________________

__________________________________________________________________

__________________________________________________________________