U.S. LASER LAWS AND REGULATIONS

The U.S. Food and Drug Administration 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. Rockwell Laser Industries has a list of state laser safety contacts.

This page will discuss the federal FDA regulations, unless otherwise noted.

What laser shows are regulated

The FDA regulates any laser shows done in public or “entered into commerce,” that use lasers over 5 milliwatts.

If you do a show in your home, for friends and family, this would not be under FDA jurisdiction (though of course you should still use safe equipment and procedures.) Once a show is done 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.

You can use lasers under 5 mW for a laser show. However, this is generally so dim that it is not worth doing for a public/commercial show. Also, even if you use lasers under 5 mW, it still may be illegal under FDA, state and/or local law to allow the beam to be aimed at or near any person.

Federal requirements to perform a laser light show

The laser equipment must be reported to FDA by the manufacturer, and the laser show user or operator must obtain a “variance” which gives permission to “vary” from FDA’s normal laser power requirements.

Equipment: FDA Form 3632

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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. Note that this 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.

Laser Show Variance: FDA Form 3147

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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.

Additionally, a successful laser light show variance application must also contain what is known as a “Show Report” which can be created using FDA Form 3640 “Reporting Guide for Laser Light Shows and Displays.” 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.

Questions and answers

For additional information

See the Links and Resources page. The pages that are listed will have additional links, such as to specific FDA documents and forms.