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Laser Light Shows

Notices to the Laser Industry

Description

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.

Uses

  • 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

Risks/Benefits

When used in the proper setting and handled by qualified professionals, laser 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 laser beam 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:

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:

Manufacturers of laser products can request an alternate means of providing radiation safety; this is called a Variance:

Industry Guidance

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 projectors 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 by the responsible parties:

  • Product Report describing the laser projector (submitted by or on behalf of the projector manufacturer) – Form 3632,
  • Laser Light Show Report describing the laser light show (submitted by or on behalf of the show manufacturer or producer) – Form 3640, and
  • Application requesting FDA approval for a variance from the demonstration laser product hazard class limit of IIIa (5mW visible output) – Form 3147.

These submissions must be prepared with either the fillable PDF forms available below or using the eSubmitter electronic submissions software.

CDRH recommends that you fill out the new CDRH Variance Package Cover Sheet  and submit it to CDRH along with the required forms to make certain that the applicant and submitter have followed the necessary instructions and to clarify to the CDRH Document Control Center (DCC) staff what is being submitted.  See CDRH Variance Package Cover Sheet available under the ‘Submission Documents’ section below.

There are several options for documents to submit.  For example, 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.

See Table for assistance:

Documents to include in your variance application package.

Product Type

Entity Type

Variance Application (Form 3147)

Show Report (Form 3640)

Laser Product Report

(Form 3632)

Other

Light Show Producer (considered a manufacturer)*

X

X

 

 

Laser Projector Manufacturer

X

X

X

 

Laser Projector Dealer/Distributor

X

X

 

 

LIP/LILI Manufacturer

X

 

X

 

LIP/LILI Dealer/Distributor

X

 

 

 

LIP/LILI User (permanent installation)

X

 

 

 

LIP/LILI User (temporary installation)

X

X

 

 

Variance Renewal

 

Only if previously submitted, report needs to be updated

 

This cover letter, missing annual reports

Variance Amendment

 

Only if previously submitted, report needs to be updated

Only if previously submitted, report needs to be updated

This cover letter including requested amendments

*The act of assembly of a laser light show using a previously manufactured laser or laser product results in the creation or manufacture of a “new” product.  The creation of this new product may involve the addition of such components as display screens, mirrors, smoke/fog and optics but may result from merely changing the intent and use of the original laser. Hence, the person who produces the “new” product is considered a “manufacturer” if such person is engaged in the business of manufacturing laser light shows. This policy, including additional details, can be found in Laser Notice #22, published on November 22, 1977.

All applicable documents, including the CDRH Cover Sheet should be emailed to the CDRH at: RadHealthCustomerService@fda.hhs.gov. 

You no longer need to separately send variance applications to Dockets Management Staff (formerly titled Division of Dockets Management).

Your firm may 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.

Submission Documents for Laser Light Show and Projector Manufacturers or Industry

Documents of Interest - Laser Notices to Industry

Other Resources

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