U.S. regulatory agencies


FDA Center for Devices and Radiological Health

CDRH - Center for Devices and Radiological Health

The Center for Devices and Radiological Health is part of the U.S. Food and Drug Administration. Under U.S. law (21 CFR 1040.10 and 1040.11), FDA CDRH regulates laser equipment plus three uses: medical, surveying/alignment, and “demonstration”. The latter includes any use where seeing the laser “dot” or beam is the primary use. Demonstration lasers include classroom use, laser pointers, and laser light shows. Since demonstration lasers are usually exclusively visible lasers, the discussion below about laser powers and safety requirements assumes that the demonstration laser emits only visible light.

Demonstration lasers below 5 mW (including laser pointers)
Demonstration lasers have a maximum power below 5 mW. This is why laser pointers cannot be 5 mW or more. However, notice a large loophole: if a laser is not sold for pointing purposes -- if it is not a “demonstration” laser -- then it can be above 5 mW. That is why battery-powered handheld lasers are often advertised on the Internet for the purpose of burning materials, popping balloons, or other general-purpose use. Since this is not “laser pointing” it is legal, even though you or I might call a battery-powered handheld laser a “pointer”.

In June 2009, FDA CDRH released a webpage and a downloadable PDF brochure, on the topic of laser pointer hazards.

Demonstration lasers above 5 mW (laser shows and displays)
Demonstration laser users, such as laser light show producers, can use powers above 5 mW if special permission is given. This “variance” allows a user to vary from the 5 mW requirement. In return, FDA CDRH mandates additional safety measures, such as having an operator at all times, and keeping the beam 3 meters vertically and 2.5 meters laterally from any audience member.

A variance is required for any laser show “introduced into commerce”, which basically means any show done in public, outside of one’s home. The variance form is available from FDA CDRH. The variance must be approved before the show can be performed.

Federal Aviation Administration

The Federal Aviation Administration does not directly regulate laser usage in airspace*. However, anyone using lasers outdoors should follow the guidelines found in FAA Order JO 7400.2 (Revision “G” as of April 2008), Procedures for Handling Airspace Matters, Part 6, Chapter 29, “Outdoor Laser Operations”.

FAA requests reports filed at least 30 days in advance of the laser usage, detailing the laser power, location with reference to local airports, control measures used, etc. This is done using two forms in FAA Advisory Circular 70-1, “Outdoor Laser Operations”. The first form, “Notice of Proposed Laser Operations”, is filled out once for a given laser location. The second form, “Laser Configuration Worksheet”, is filled out once for each laser at the location.

The FAA will review these forms -- hopefully within the 30 day period. They will send either a “letter of objection” or a “letter of non-objection”. Note that FAA is not approving the laser use; they are merely either objecting to it or not objecting to it. It is up to the laser user to follow the procedures outlined in their submission, in order to keep the laser from hitting any aircraft or otherwise causing problems.

If the laser use is for a show or display, there is a more stringent regulatory process. CDRH regulates laser shows since they fall under the “demonstration” category discussed above. CDRH will not give approval for an outdoor laser show unless it has been reported to FAA, and FAA has returned with a letter of non-objection. In this way, CDRH can legally stop outdoor laser show or demonstration use. (FAA has no direct authority. However, almost all professional outdoor laser users voluntarily submit to FAA and will not use lasers until they receive a letter of non-objection.)

*”Lasers in airspace” are defined by FAA as ANY use outdoors, even between two buildings across a street. This is because a helicopter may be able to fly between the buildings. Also, there is no minimum altitude; if your laser beam is 10 feet high across a field, the FAA still wants to know about it. This is because misalignment, accidents, misuse, etc. may cause the laser beam to go into airspace where it was not originally intended.

Other U.S. laser regulators

In addition to CDRH, the other federal agency with direct laser authority is U.S. Department of Labor’s Occupational Safety and Health Administration regulates occupational exposure to lasers, but not non-workplace safety hazards.

Some states and localities have laws regulating laser equipment or use. In addition, these laws may be of interest for those with high-powered lasers:

  • Texas and Illinois require registration of Class 3B and Class 4 lasers (those above 500 mW).
  • New York State has requirements for “low-intensity” and “high-intensity” lasers; it is unclear whether laser pointers under 5 mW are included or are enforced under this rule (“Industrial Code Rule 50”). Operators of mobile lasers (e.g., not fixed as in a factory) require an operator’s license from the state’s Department of Labor. Again, it does not seem that users of pointers under 5 mW are required to have an operator’s license.
  • Other states with registration requirements for certain lasers or uses include Georgia and Arizona.

If you have any questions, check with CDRH for a list of state and local agencies. Also, do an Internet search for your state’s name, plus terms such as “laser registration”.