The U.S. Food and Drug Administration (FDA) regulates laser light show displays. In addition, some states and localities require registration or regulation of the lasers, show equipment and/or the laser operators.
This page will discuss the federal FDA regulations, unless otherwise noted. For states and localities, see this page.
If you have any questions, please contact the FDA's Center for Devices and Radiological Health, as CDRH is the final arbiter of FDA regulations and requirements.
FDA regulates any laser shows done in public or “entered into commerce,” that use lasers over 5 milliwatts.
Once a show with lasers over 5 mW is done in public or for commercial purposes, the FDA has jurisdiction. For example, if there is an admission fee to the show or to the overall environment (a concert or disco). This also applies if someone is being paid for the laser lights, or for a function that includes the laser lights (such as being a DJ). While it is unclear if FDA has jurisdiction over a completely free show done in public, the agency would normally assert its jurisdiction since it exists to help protect the public.
If a laser show is performed outdoors and the beams are not terminated (e.g., meaning that beams can enter navigable airspace), FDA will require the laser show to be submitted to the Federal Aviation Administration (FAA) in advance for review. FAA requests at least 30 days notice in order to study the show and how it relates to air traffic. FAA will issue either a "letter of non-objection", or they will object to one or more elements of the show. FDA will not allow any FAA-objected elements to be included in laser shows.
A federal law prohibits laser pointers from knowingly being aimed at aircraft, or at the flight path of an aircraft. Technically this applies only to "pointers", and laser light shows are different from pointers as defined in the law. However, it is still general Federal Aviation Administration (FAA) policy to object to visible laser beams knowingly being aimed at or near aircraft, whether they are from pointers or laser show projectors.
Beams will either need to be terminated, or spotters (or other FAA-reviewed methods) will be used to ensure that beams are not aimed at or near aircraft.
When are laser beams adequately terminated? FAA has written:
"…laser beams must be terminated at the site and will not enter navigable airspace. 'Terminated', in this instance means that all beams are confined by an object found suitable by the Food and Drug Administration (FDA) and has no effect on Air Traffic. No beams may penetrate through, or be reflected from, the terminating surface and [be] allowed to enter any airspace useable by aircraft and/or helicopters, including that airspace used for arrival and departure from any airports, heliports and/or sea lanes."
Whether beams are terminated relies in part on whether the termination surface fully stops the beams. For example, no beams on trees if you can see sky through the leaves (including when wind is blowing) and no beams reflecting off building windows if the beams will enter airspace.
Termination also relies on whether aircraft could reasonably be expected to fly between the laser source and the termination point. Especially consider helicopter traffic — could a police or medical helicopter fly or land in the beam path in case of an emergency?
The laser equipment must be reported to FDA by the manufacturer, the laser show user or operator must obtain a “variance” which gives permission to “vary” from FDA’s normal laser power requirements, and the laser show user or operator must file a Laser Light Show Report with FDA.
In addition, you must file an Annual Report each year by September 1.
The four required documents are discussed below.
Laser Product Report: FDA Form 3632The laser projector (this includes the laser and anything to shape, steer or modulate the light) must be reported in advance using FDA Form 3632, “Guide for Preparing Product Reports on Lasers and Products Containing Lasers.”
If there is a change to an already-reported laser or projector, a Supplemental Report can be filed. And each year, by September 1 the manufacturer must submit an Annual Report covering the previous July 1 to June 30 time period. This requirement also applies to all variance holders (see below), regardless of whether they are a manufacturer or not.
Any laser demonstrations, displays or shows that use lasers above 5 milliwatts must have a “variance” from FDA. This document gives the variance holder permission to “vary” from the 5 milliwatt limit, by using more power.
You apply for a variance using FDA Form 3147, “Application for a Variance from 21 CFR 1040.11(c) for a Laser Light Show, Display or Device.” This is a four-page form that you fill out, stating why you need the variance and what effects will be used.
In some respects it is a check-off-the-box form. You put a check box by items such as the show location, length of tour (if applicable), laser effects used, etc. There is a long list of “alternate means of radiation protection,” which are in essence the requirements that FDA is putting on you, as the laser show operator/producer.
In addition to the variance, persons wanting to do laser shows must also submit the Laser Light Show Report (Form 3640) described below. This report is a more comprehensive look at how you intent to use the laser, and asks for more details about proposed safety measures.
Once you have received a variance approval letter from FDA, you can then legally do laser shows (under the terms of your variance) under federal law., There still may be some state or local laws you also need to follow.
Paperwork Reduction Act statement
The paperwork burden is estimated to average 1/2 hour of work, "including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information."
That may be true for someone experienced in doing variances. But for a first time person, the time would be much greater. ILDA suggests using companies that specialize in assisting with certification, variances and importation. They are listed on the U.S. laws for LDI show page.
Annual Reports due each year
As part of your variance, you must file an Annual Report each year by September 1. As of October 2017, laser show companies have had their variances cancelled if the Annual Report was not filed by this date. See FDA Form 3636, the "Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light Show Products" for more information.
The company "Annual Laser Report LLC" can assist with filling out and submitting the Annual Report, for a fee. This service may also be available from companies that can assist with certification, variances and importation that are listed on the U.S. laws for LDI show page.
Laser Light Show Report: FDA Form 3640
In addition to the Laser Show Variance, you must also submit FDA Form 3640, "Reporting Guide for Laser Light Shows and Displays." This is similar to the Laser Product Report, FDA Form 3632, described above.
To give you an idea of what the FDA requires, here is the Introduction to the FDA's Reporting Guide for Laser Light Shows and Displays:
This guide is to be used for reporting laser light shows or displays incorporating Class IIIb or Class IV lasers only. Separate reports are not required for shows or displays that incorporate Class I, IIa, II, or IIIa laser projection systems. Such show descriptions must be included in the user instructions and the report for the laser projector.
Laser projectors used in any light shows or displays regardless of the class of the projector must be certified by the manufacturer and reported using the guide titled, "Guide for Preparing Laser Product Reports for Lasers and Products Containing Lasers," HHS publication FDA 86-8259. These guides assist manufacturers in providing the information that the Center for Devices and Radiological Health (CDRH) needs to determine how laser light show projectors and laser light shows comply with the Federal standard for laser products (21 CFR 1040.10 and 1040.11) and with the conditions of and an approved variance.
An approved variance from section 1040.11(c) is required for demonstration laser products (including projection systems and shows) that would be Class IIIb or Class IV. Applicable reports and application forms must be submitted and the variance approved by CDRH prior to the sale, lease, or use of a Class IIIb or IV projector or laser light show.
A report is to be submitted for each unique laser projector, light show, or display. If you later plan to add effects to a previously reported show or introduce a material change in the show, auxiliary projection equipment, or projector, you must submit a supplementary report describing the additions or changes. If you plan to introduce a projector or show that is substantially different, you must submit and an additional laser product or light show report.
If you are the manufacturer of the projector and a Class IIIb or IV light show, then the general laser product reporting guide must be used to provide a complete report on the whole projection system and this laser light show guide to describe all the effects. In the Laser Product Report you would identify the projector, including auxiliary components in the projection system, and describe any aspects of the design of those components that satisfy a requirement of the variance or the standard.
If the projector or projection system was purchased and is certified by its manufacturer, you may provide information concerning the projector by reference to the manufacturer's report on the projector, specifying the model number, model name, and the CDRH accession number of that report.
However, if you have modified the projector (changed the protective housing, interlocks, apertures, installed lasers of a different class, added remote controls, etc.) or added auxiliary equipment such as mirrors, mirror balls, fiber optics, remote scanners, projection screens or other surfaces as targets, etc., the modified projection system must be reported by you, using the general laser product reporting guide. As above, the projector manufacturer's report may be referenced for any items of information that were not affected by your modifications.
A Laser Product Report or Supplemental Report must be submitted prior to introduction of changes. In addition, you should check your variance approval letter, specifically paragraph D and the conditions in any attachments, before you produce new shows to be certain that your variance allows the proposed changes. If it does not, then you must apply for and receive an approved amendment to your variance prior to introducing your new show or projector into commerce.
Your variance will be approved for a specific period of time. If you wish to produce shows after the expiration date, several months prior to its expiration date you must request an extension in writing. Variance extensions and renewals are subject to the adequacy and timeliness of all required reports, show notifications, and recordkeeping. Noncompliances in your shows, projection equipment, or quality control records would be grounds for denial of your request, or further regulatory actions.
Annual Report (due Sept. 1 of each year): FDA Form 3636In this document, you tell FDA about your laser shows and equipment usage, from July 1 of one year to the following June 30 of the next year. You must file by September 1, each year. (Should you miss that date, at least get it in by December 31.)
If you were issued a variance after a certain date in the year, you would not be required to submit an Annual Report for your first year. FDA in the variance notification letter will let you know when your first Annual Report is required.
The paperwork burden is estimated to average 18 hours of work, "including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information."
The company "Annual Laser Report LLC" can assist with filling out and submitting the Annual Report, for a fee. [As of September 2021 their website appears to be broken or not loading.] This service may also be available from companies that can also assist with certification, variances and importation that are listed on the U.S. laws for LDI show page.
