The 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 you buy a pre-made laser projector, it should already have been reported to FDA, and received an “Accession Number” from FDA. This accession number is sometimes reported by manufacturers as a variance number since accession numbers often become variance numbers once FDA has approved a manufacturer’s submission.
• If you make your own laser projector for commercial use as described above, you are a manufacturer. You must fill out and submit FDA Form 3632 to the agency. Do not submit it using the same procedure as submitting variances; the procedure is different. Note that manufacturing a projector could simply include putting scanners or a diffracting glass in front of a general-purpose laser. By doing this, you have changed it from a general purpose laser to one that has a purpose of demonstration or display — so you are a manufacturer to FDA. When FDA receives your report, they will issue an “Accession Number.”

The Accession Number merely means that FDA has received the report — not that it has reviewed or approved/disapproved the projector. While having an Accession Number is not a guarantee that a projector is safe or legal, it does mean that at least a manufacturer has submitted a laser product report to FDA. (Be careful; some companies unknowingly or deliberately use Accession Numbers for the wrong model or even a different manufacturer.)

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.

• Because of the reporting requirements, if you are doing public/commercial laser shows, it is strongly suggested that you purchase a pre-made laser projector from a reputable manufacturer. The manufacturer will take care of filing the initial, supplemental and annual reports.

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.

You can submit the variance electronically if you wish.

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.

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.

• Do not submit it using the same procedure as submitting variances; the procedure is different.

The paperwork burden is estimated to average 24 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."

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.

Each year you must submit FDA Form 3636, "Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light Show Products."

In 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. 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.

Legally you cannot use Class 3B or Class 4 laser equipment for public/commercial displays until your variance has been approved by the FDA.

In fact, in most cases, legally the manufacturer cannot even give you the laser equipment until your variance is approved. (Being able to physically take possession of high-powered laser equipment before you can show proof of an approved variance may be a red flag that the equipment is not compliant.) The procedure is described in FDA’s Laser Notice 51.

Since it may take a number of weeks — or perhaps even longer depending upon how you file — for variances to be approved by FDA, this means you need to plan ahead. It helps greatly to buy your laser projector from a manufacturer who is familiar with the variance process, and who can help you file (or can file on your behalf).

While some manufacturers may provide the laser projector in advance of you getting an approved variance, this may be illegal (even if they say “Oh, you just have to submit the variance”).

The short answer is “no”, normally you cannot permit laser light to touch or go near the audience or performers. Under condition 13(a) of the variance application, beams must be kept at least 2.5 meters laterally and 3.0 meters vertically from audience access. This means laser beams should be kept approximately 10 feet above any surface upon which someone can stand, and approximately 8 feet in lateral separation.

FDA states that this restriction applies to almost any visible laser light, including light from lasers that emit less than 5 mW, and “star projectors” that split light up into beams each of which is less than 5 mW. There is some debate about this issue among safety experts, but be aware that in general, if you put low-powered lasers directly into the audience, this is potentially hazardous and probably illegal.

By using special equipment and techniques, it is possible to expose an audience to laser light. There are three main ways:

1. Use of beam-splitting devices such as a “star projector” or diffraction grating that splits a single beam into dozens or hundreds of multiple, lower-powered beams.
2. Use of high-intertia scanning devices such as a rotating mirror ball, or projector on a rotating platform where, if the movement motor fails, this failure is detected and the beam is shut off in time to prevent exposure above the Maximum Permissible Exposure limit.
3. Use of low-intertia scanning devices such as galvanometer scanners (e.g., beam/graphic projectors) where multiple systems are used to detect scan failure and prevent exposure over the MPE.

Most of these methods require laser power meters to measure laser irradiance at the point of closest audience access. They may also require additional specialized equipment. The latter two methods also require effective scan-failure detection equipment.

The complexity of safely using scanning devices (items 2 and 3 above) limits their use to professional companies with special audience-scanning variances and projectors. Usually these are used for major tours, TV shows and other high-profile, high-budget projects.

There are companies experimenting with or even selling projectors that are said to be “audience safe” if installed at a certain distance, for example, 30 meters minimum from the point of closest human access. In theory this can work if the laser power and beam divergence are at a known, fixed value that cannot be exceeded.

However, different implementations of this technique may make it more or less safe. In all cases, we recommend ensuring that the system you may wish to use is covered by an audience scanning variance issued to the manufacturer of the system. Minimally, this means that the manufacturer has reported the system to the FDA and FDA has agreed that the reported control mechanisms are sufficient to maintain public safety.

For these reasons, at this time we do not recommend the use of audience scanning projectors for persons without deep experience and training in laser safety.

Laser shows and displays used outdoors trigger special requirements from the FDA. Under the terms of a laser show variance, FDA will require the variance holder to file a Notice of Proposed Outdoor Laser Operations with the Federal Aviation Administration, using Advisory Circular 70-1. This should be filed at least 30 days in advance of the show, when possible. If the FAA does not object to the proposed operation, then the FDA will grant the variance (assuming of course that all other variance conditions are also met).

In general, any laser beam that goes into airspace, or could go into airspace, triggers the FDA’s requirement for FAA review. This could occur even on private property, or if a beam travels between two buildings on a street. Another scenario is that a beam may miss a mirror or termination surface, and may inadvertently go into airspace. FAA’s rationale for requiring review even of small airspace zones is that a police or emergency helicopter may need to fly into the area; thus the beams need to be monitored and to be safe for air crews.

Usually, the primary ways that laser shows meet FAA’s requirements are by using spotters to turn off the beams if aircraft are seen, and keeping the beams away from airports and flight paths. Radar or other automated detect-and-shutter methods are normally too expensive to employ for the short duration of a laser show.

The above discussion has focused on U.S. federal requirements. See this page for more information about state and local laws.

Many countries regulate laser light shows. See the page on worldwide audience scanning laws and the Links and Resources page for any links to non-U.S. laws.