How the FDA Holds the Leash on IMAX and SONY (and a couple of other companies)

Prototype Kodak Laser Projector (C) Kodak

During Kodak’s presentation at the GSCA Film Expo, it was brought up that their laser light cinema projector had just received FDA approval.  JW, sitting next to me, wondered what the Food and Drug Administration had to do with anything laser-rific.  The answer is simple and comes straight from the FDA’s website:

FDA is the federal agency responsible for ensuring that foods are safe, wholesome and sanitary; human and veterinary drugs, biological products, and medical devices are safe and effective; cosmetics are safe; and electronic products that emit radiation are safe. FDA also ensures that these products are honestly, accurately and informatively represented to the public. Some of the agency’s specific responsibilities include:

Radiation-Emitting Electronic Products
  • radiation safety performance standards for microwave ovens, television receivers, diagnostic x-ray equipment, cabinet x-ray systems (such as baggage x-rays at airports), laser products, ultrasonic therapy equipment, mercury vapor lamps, and sunlamps
  • accrediting and inspecting mammography facilities

The FDA continues:

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, 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

Manufacturers of lasers for entertainment purposes are subject compliance with the following laws: Federal Food, Drug and Cosmetic Act (FFDCA), Chapter V, Subchapter C;  and Title 21, Subchapter J, Parts 1000-1005 and Parts 1010-1040.  Laser projectors are considered “demonstration laser products,” defined by 21 CFR 1040.10(b)(13) as “a laser product manufactured, designed, intended, or promoted for purposes of demonstration, entertainment, advertising display, or artistic composition.”

According to the FDA website:

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.

For the record, those hand-held laser pointers used for presentations or to drive dogs and cats nuts  are also regulated by the Food and Drug Administration.

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