3-Step Checklist for FDA Approval of your Laser Light Show

Anywhere, for any occasion, laser light shows can be employed, including during musical performances, corporate events, sporting events, game openings, trade exhibitions, significant outdoor events, movie premieres, and audience scanning. Exciting 3-D effects can be produced by combining laser beams with projected images. Software for outdoor laser light show equipment is frequently used to match visual effects with musical or vocal performances.

Safety for Light Shows
Audience safety, aircraft safety (for outdoor performances), and regulatory compliance are the three main light show safety considerations.

Class II to Class IIIa, Class IIIb, and even Class IV lasers have been utilized in light shows (see [9] and [10]). But every laser projector must be safe first. To change a product’s original formulation, the FDA needs to give its approval. This is known as a variation, and extra precautions must be taken to ensure safety.

The following are the FDA’s safety guidelines for laser light shows:

Manufacturers must obtain an FDA-approved variance before Class IIIb or Class IV lasers are sold, used in performances, or otherwise introduced into commerce for demonstration or entertainment reasons.
Manufacturers of lasers include those who create laser goods and those who are paid to create, construct, or alter laser projectors and/or light shows.
A manufacturer is a who? Even if they just design the show or change the purpose of a laser without otherwise changing the equipment, a musical group or other individuals who put up light shows are still regarded as manufacturers. The intended use of the laser is what justifies the necessity for the variance; according to the FDA Variance Package ([6], link below): A “new” product is created or manufactured when a laser light show is put together utilizing a previously produced laser or laser product.

FDA regulations for approving laser light shows
You must adhere to the FDA’s guidelines if you wish to produce a laser light show.

Only Class IIIa laser projectors with 5 milliwatts of power and a visible wavelength range of 400 to 710 nanometers may be used for light shows.

The four FDA reports you must submit if your laser light show use Class IIIb and IV lasers are listed below:

FDA Form 3632, Product Report [2]:
FDA Form 3640, Laser Light Show Report [3], is available for download at
Request for a Variance [4] – Download the FDA Form 3147 at
Annual Report [5] – FDA Form 3636: available for download at
As a manufacturer (again, see the point above) or distributor, the FDA also supplies a cover sheet for your Variance Package [6] describing the reports and when they are required:

Checklist in three steps
Utilize this three-step checklist to prepare in advance for your reporting on laser light shows:

In the Laser Product Report, first list the specifications of each laser product type or family you intend to employ.

Preparing a Laser Product Report: Name, Address, and Contact
Information about the importing agent
Names, brand names, model numbers, and designations for model families
Any previous modification(s)
Various other untouched approved laser items
any unlicensed laser products
Laser devices that are detachable [1040.10(c)(2)]
Additional product power, rating, or categorization information
Second, include information on the performance in the Laser Light Show Report.

Show information from Laser Light Show Report:
maker and person in charge of the light show
Almost any importer
Is this a fresh laser light show report or a supplement report as per 21 CFR 1002?
If additional, include details from the original report.
Name of a light display or show
places, times, and dates
Include a copy of the approval or variance request
maker, model, and CDRH number of projection equipment
types of locations
If a tour, please specify.
Specify the lighting effects that will be applied.
Diagrams and sketches of the location, showing where the projector or other devices are located.
Path of reflected and direct laser beams
levels of laser radiation
laser beam separations at their smallest
any beams that are directed or reflected at the audience or performers
Include drawings
Give details about radiation levels and calculations.
Additionally, ponder the following:
Are you scanning the audience?
Is it possible to view the laser beams?
Any above Classes I or II?
Is the program continuously controlled by an operator?
Do the operator’s responsibilities change throughout the show?
Can the operator see everyone in the room and every beam path?
Is there a helper keeping an eye on things?
If so, list each person’s name and function.
How and if your laser operator is qualified
Exists a different designated authority figure?
What training and experience do they have?
Exist controls that are simple to use to halt the performance in an emergency?
In what place are the controls?
Do you follow any written policies?
Are these methods documented in writing somewhere?
Which additional regulatory processes will be adhered to?
Is regulatory notice required?
Create the Application for Variance in the third step.

You must be aware of the following in order to request a variance:
What kind of product need a change?
Will there be projectors used?
What location will host the light show?
The light show will be utilized either once or on a tour basis. How much time will the tour last?
How long can we expect to utilize the product?
What kind of laser effects are you going to use?
What is the required deviation or variation from the relevant standard?
Why is the change required?
What kind of safety precautions will you take?
Operators of laser light shows need to be well trained to guarantee safety. Exciting and potent displays are produced by the powerful lasers utilized in light displays. But you must also keep in mind that if humans are exposed to the direct beams, they can suffer eye damage and skin burns. Additionally, they might endanger airplanes if laser beams from the event shine directly on the aircraft.

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