3-Step Planner for Laser Light Show FDA Approval

  • Posted on May 4, 2018

Laser light shows can be used anywhere for any occasion: Musical acts, Corporate events, Sporting events and game openings, Trade shows, Major outdoor events, Movie premiers and Audience scanning

Lasers beams and graphics create exciting 3-d effects. Laser mapping is popular with architects who can map the edges of a building or surface. Laser light show software synchs the effects with music or vocals.

The 3 light show safety issues are: Audience safety, Aircraft safety (outdoor shows) and Regulatory compliance.

Lasers used in light shows are typically Class IIb and even Class IV. But safety is paramount. The FDA requires permission to deviate from a product’s original form. This is called a variance and requires additional steps to assure safety.

The FDA’s laser light show safety rules are:

• Before Class IIIb or Class IV lasers are sold, used in performances or otherwise introduced into commerce for demonstration or entertainment purposes, manufacturers must have an approved variance from FDA.
• Laser manufacturers include people who make laser products and people who receive compensation to design, assemble or modify a laser projector and/or light show.

Who is a manufacturer? A musical group or others who assemble light shows are considered manufacturers even if they only design the show or change the purpose of a laser without altering the device in any way. This is what creates the variance.

If you want to create a laser light show, you must follow the FDA’s procedures.

Laser products used for light show purposes are limited to Class IIa laser projectors with 5 milliwatts of power and a visible wavelength range of 400 to 710 nanometers.

If your laser light show uses Class IIIb and IV lasers, here’s the 3 FDA reports you’ll need:
[provide links to the pdfs]
• Product Report – FDA Form 3632
• Laser Light Show Report – FDA Form 3640
• Application for Variance – FDA Form 3147_08-25-17

Plan ahead using this checklist:

Laser Product Report Prep

First, know the specifics of each laser product model or family you intend to use:

• Manufacturer name, address, contact
• Any importing Agent information
• Names, brand names, model numbers and model family designations
• Previous modification, if any
• Other unmodified certified laser products
• Any noncertified laser products
• Any removable laser systems [1040.10(c)(2)]
• Additional information

Laser Light Show Report

Next, give details of the show:

• Manufacturer and responsible person for light show
• Any importing agent
• Per 21 CFR 1002, is this a new laser light show report or supplemental report?
o If supplemental, provide original report information
• Light show or display name
• Locations, dates and times
• Include a copy of variance request or approval
• Projection equipment manufacturer, model and CDRH number
• Types of venues
• One time or tour
• Light show effects to be used
• Diagrams and drawings of venue including
o Location of projector or other devices
o Direct and reflected laser beam path
o Laser radiation levels
o Minimum separations of laser beam
o Any direct or reflected beams into audience or performers
• Attach drawings
• Describe radiation levels and provide calculations
Also ask yourself these questions:

• Are you doing audience scanning?
• Can anyone see the laser beams?
o Are any above Class I or II?
• Is the show under continuous operator control?
• Does the operator have other duties during the show?
• Can the operator see the audience and all beam paths?
• Is there an assistant providing surveillance?
o If so, identify each
• Is your laser operator qualified and how?
• Is there another designated responsible person?
o What is his/her experience and training?
• Is there easy to access controls to stop the show in case of an emergency?
o Where are the controls?
• Do you have written procedures?
• Are written records of these procedures kept?
• What other regulatory procedures will be followed?
• Is regulatory notification necessary?

Application for Variance

To get a variance, you’ll need to know:

• What type of product needs a variance?
• Will projectors will be used?
• Where will the light show be staged?
• Will the light show be used once or on a tour basis? How long will the tour run?
• How long will the product be in use?
• What type of laser effects will you use?
• What is the deviation or variance from the applicable standard you need?
• Why is the variance necessary?
• What type of safety measures will you follow?

Laser light show operators must be properly trained to ensure safety. The high-powered lasers used in light shows create exciting powerful displays. They can also cause eye damage and skin burns to people if exposed to the direct beams. They pose hazards to aircraft if laser beams shine directly on a plane.

https://www.fda.gov/radiation-emittingproducts/radiationemittingproductsandprocedures/homebusinessandentertainment/ucm118907.htm

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