Lasers and laser projection systems are used with other optical equipment, such as projection screens, mirror balls, remote projector heads, and fiber optics, to produce colorful, dramatic displays for entertainment purposes.
Laser stands for Light Amplification by the Stimulated Emission of Radiation. One basic type of laser consists of a sealed tube, containing a pair of mirrors, and a laser medium that is excited by some form of energy to produce visible light, or invisible ultraviolet or infrared radiation. Ordinary light, such as that from a light bulb, has many wavelengths and spreads in all directions. Laser light, however, has a specific wavelength. It can be focused into a tight beam and can concentrate very high-intensity light at large distances from the laser.
- Music events
- Restaurants and Nightclubs
- Theatrical events
- Meeting venues
- Permanent light shows
- Laser effects with a fireworks display
- Art and advertising displays
- Laser video projection systems
- Artistic and entertainment lighting displays
When used in the proper setting and handled by qualified professionals, lasers light shows can provide dramatic displays and as backdrops to other entertainment and venues.
While the lasers themselves can cause injuries, laser light shows that are produced in accordance with FDA regulations keep hazardous lasers away from the audience. For shows where the lasers could fall on the crowd, the power of the laser is kept below levels know to be hazardous.
Risks from improperly handled lasers include:
- Eye injury
- Skin burns
- Other safety risks for pilots, drivers and others who may be distracted or temporarily unable to see
Manufacturers of electronic radiation emitting products sold in the United States are responsible for compliance with the Federal Food, Drug and Cosmetic Act (FFDCA), Chapter V, Subchapter C - Electronic Product Radiation Control.
Manufacturers of laser products are responsible for compliance with all applicable requirements of Title 21 Code of Federal Regulations (Subchapter J, Radiological Health) Parts 1000 through 1005:
- 1000 - General
- 1002 - Records and Reports
- 1003 - Notification of defects or failure to comply
- 1004 - Repurchase, repairs, or replacement of electronic products
- 1005 - Importation of electronic products
In addition, laser products must comply with radiation safety performance standards in Title 21 Code of Federal Regulations (Subchapter J, Radiological Health) Parts 1010 and 1040:
- 1010 - Performance standards for electronic products: general
- 1040.10 – Laser products.
- 1040.11 – Specific purpose laser products.
Manufacturers of laser products can request an alternate means of providing radiation safety; this is called a Variance:
Laser projectors and laser light shows are “demonstration laser products” as defined by 21 CFR 1040.10(b)(13):
“Demonstration laser product means a laser product manufactured, designed, intended, or promoted for purposes of demonstration, entertainment, advertising display, or artistic composition.”
Lasers promoted for entertainment purposes or amusement also meet FDA’s definition for “demonstration laser products.”
Laser products promoted for demonstration purposes are limited to hazard Class IIIa by FDA regulation 21 CFR 1040.11(c). This means that pointers are limited to 5 milliwatts output power in the visible wavelength range from 400 to 710 nanometers. There are also limits for any invisible wavelengths and for short pulses. Laser light show projectors therefore may not exceed the accessible emission limits of CDRH Class IIIa. Laser light show manufacturers must submit a variance request for FDA approval in order to sell and operate higher class (Class IIIb and IV) laser light show equipment.
Prior to using Class IIIb and IV lasers for a laser light show in the United States, the following documents must be submitted to the FDA:
- Product Report describing the laser projector,
- Laser Light Show Report describing the laser light show, and
- Application requesting FDA approval for a variance from the demonstration laser product hazard class limit of IIIa (5mW visible output).
These submissions must be prepared with either the CeSub electronic submissions software or the paper reporting guides listed below.
If you are purchasing a certified laser projector for which a product report has already been submitted, you need only submit the laser light show report and variance application.
Your firm can begin to produce laser light shows only after receipt of a variance approval letter from FDA indicating the conditions under which you may produce the laser light show or distribute laser light show projectors.
Required Reports for Laser Light Show and Projector Manufacturers or Industry
Reporting Guide for Laser Light Shows and Displays (PDF)(PDF - 919KB) Application for a Variance From 21 CFR 1040.11(c) for a Laser Light Show, Display, or Device (PDF)(PDF - 715KB) Guide for Preparing Product Reports on Lasers and Products Containing Lasers (PDF)(PDF - 1MB) Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light Show (PDF)(PDF - 811KB) FDA eSubmitter
Documents of Interest - Laser Notices to Industry
Immediately in Effect Guidance Document: Classification and Requirements for Laser Illuminated Projectors (LIPs) - Guidance for Industry and Food and Drug Administration Staff(PDF - 103KB)
- Federal Register - Laser Products; Proposed Amendment to Performance Standard
Compliance Guide for Laser Products (FDA 86-8260) (PDF Only)(PDF - 105KB) Notices to the Laser Industry Laser Products - Conformance with IEC 60825-1 and IEC 60601-2-22; (Laser Notice No. 50) Responsibilities of Laser Light Show Projector Manufacturers, Dealers, and Distributors; (Laser Notice 51) Procedures for Renewal and Amendment of Certain Laser Light Show Variances (Laser Notice 55) FDA Safety Notification: Risk of Eye and Skin Injuries from High-powered, Hand-held Lasers Used for Pointing or Entertainment[ARCHIVED] Frequently Asked Questions Regarding the Laser Notice 53 - Guidance for Industry and FDA Staff - Approval of Alternate Means of Labeling for Laser Products (issued March 23, 2007) Date of Manufacture Label on Radiation-Emitting Consumer Electronics Quality Control Practices for Compliance with the Federal Laser Product Performance Standard(PDF - 1.1MB) Tabulated Values of Accessible Emission Limits for Laser Products(PDF - 1.7MB) Guidance for Industry and FDA Staff - Addition of URLs to Electronic Product Labeling
Ch. 29 of FAA Order 7400.2F, Procedures for Handling Airspace Matters, Outdoor Lasers Records and Reporting (Radiation-Emitting Products) Importing and Exporting Electronic Products Date of Manufacture Label on Radiation-Emitting Consumer Electronics Laser Light Show Safety -- Who's Responsible (FDA 86-8262) (PDF Only)(PDF - 883KB) Does the Product Emit Radiation? Getting a Radiation Emitting Product to Market Medical Lasers Laser Products and Instruments FAA: Laser Hazards In Navigable Airspace Board of Laser Safety
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