FDA/CDRH

The Center for Devices and Radiological Health is part of the U.S. Food and Drug Administration. 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.
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, 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, 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 CDRH. The variance must be approved before the show can be performed.
Other U.S. laser regulators
In addition to CDRH at the federal level, the 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”.