The following information comes from an experienced laser user. It is presented here at LaserPointerSafety.com to provide a starting point for guidance. Do not rely on this for legal advice -- you would need to independently investigate and evaluate the statements below. One starting point is the website for the U.S. federal laser safety agency, the FDA’s Center for Devices and Radiological Health (CDRH).
You may also want to check out the related page on this website describing what happens if you break the rules.
Rules and regulations
1. Lasers in the USA are governed by specific rules and regulations listed in the Code of Federal Regulations, 21 CFR 1040.10 and 1040.11.
2. Lasers that are brought into commerce in the USA (sold, imported, exported or USED) in the USA are REQUIRED BY LAW to meet minimum safety requirements set forth by the above CFR (Code of Federal Regulation).
3. Briefly, these regulations and safety standards for include but ARE NOT limited to:
- Delayed lasing of output after power is applied.
- Key-operated activation (Key CAN NOT be removed in the "ON" position. Laser pointers can have momentary switches.)
- Mechanical shutter of laser output. Either automatic OR human activated.
- Beam attenuation
- PROPER labeling of laser. (i.e.- CLASS 3B laser output MAX. power output 600mW @532nm) label CAN NOT be broad and general. PROPER labeling requirements can be found in 1040.10; scroll down to see labeling requirements.
- Date and location of manufacture
- Certification label
AGAIN - the above is NOT a complete list of what needs to be accomplished to have a "legal" laser system. it will give you an idea though.
Laser systems do not need to be "registered" per-se with the government. Instead, manufacturers must submit a product report which can be found here.
The product report describes how the manufacturer or person introducing the laser into commerce demonstrates that it meets the minimum requirements for safety. Until that report is submitted AND APPROVED (e.g. you receive an accession number or “variance” issued by the CDRH) the laser system is NOT "legal."
Once it is legal, the laser is also eligible for re-sale, as long as the re-sale guidelines are met also.
Laser modules (NOT pointers or self-contained lasers, but laser heads without power supplies) DO sometimes fall into a "gray area" as an Original Equipment Manufacturer device. This is because modules can be sold to end users who in turn certify the final, completed laser or laser-containing product as a certified and varianced laser system.
Basically, there is no easy way around the CDRH’s system. They understand that sometimes people sell components as “OEM parts”, but really are assemble-it-yourself kits. If there is no intent to manufacture certified, varianced final products, this is illegal.
FDA/CDRH crackdown in spring 2009
The FDA is SEVERELY and AGGRESSIVELY cracking down on high powered pointers. They are dangerous, being abused, not safe and are HIGHLY being used for criminal mischief which is making professionals REALLY pissed off in the laser community. One bad apple in the laser industry REALLY does make an impact on all of us. Lasers are a highly publiciized industry.