Radiation-Emitting Products
Laser Light Shows
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
- Fire
- Other safety risks for pilots, drivers and others who may be distracted or temporarily unable to see
Laws, Regulations, & Standards
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.
Submissions/Reporting forms
If you want to submit using the eSubmitter software (CeSub), you may follow packaging instructions to transfer the submission to CD to mail to CDRH or, to submit truly electronically, you should start the FDA Electronic Submissions Gateway setup process now by following the instructions given on http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/defaullt.htm
Hard Copy Submissions
- Reporting Guide - Radiation Safety Product Report for Laser Light Shows/Displays, September 1995
- Variance Application for Laser Products used for Light Shows and Displays
- Reporting Guide - Radiation Safety Product Report for Laser Products, September 1995 [Microsoft Word version]
- Reporting Guide - Annual Reports, Revised September 1995 [Microsoft Word version]
Laser Notices
- Laser Notices to Industry (All)
- Laser Notice 50 - Conformance with IEC 60825-1, Am. 2 and IEC 60601-2-22 (Final Guidance for Industry and FDA)
- Laser Notice 51 - Responsibilities of Laser Light Show Projector Manufacturers, Dealers, and Distributors (Final Guidance for Industry and FDA)
- Laser Notice 55 - Procedures for Renewal and Amendment of Certain Laser Light Show Variances (Guidance for Industry and FDA Staff)
Here are other useful links and documents in Portable Document Format (PDF) that are viewable with Adobe Reader or your web browser.
- Chap. 29 of FAA Order 7400.2F, Procedures for Handling Airspace Matters, Outdoor Laser Operations
- Regulated Industry: Reports and Recordkeeping
- Regulated Industry: Imports & Exports
- Date of Manufacture Label for Electronic Products Subject to Radiation Standard
- Laser Light Show Safety: Who's Responsible?
- Device Advice: Does the Product Emit Radiation?, July 2006
- Frequently Asked Questions for Manufacturers of Electronic Products that Emit Radiation, April 2006
For information on other uses for lasers, see: