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Federal rules for those selling laser pointers in the U.S.
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, and for consumers, Federal rules for those owning or using lasers in the U.S.
The FDA has a "Red List" of consumer laser products which can be detained without physical examination, due to violating various sections of the Federal Food, Drug, and Cosmetic Act. The list is Import Alert 95-04.
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 publicized industry.
UPDATE: The following information was originally written by LaserPointerSafety.com in February 2011.
FDA/CDRH re-interpretation of SLA lasers
As a response to the introduction of 1-watt blue lasers in the summer of 2010, CDRH is attempting to crack down on consumer-grade handheld portable lasers. They are doing this by a new interpretation of CDRH’s existing authority over users of “surveying, leveling and alignment” (SLA) lasers. This is one of the three uses that CDRH can regulate under 21 CFR 1040.10; the other uses are medical and “demonstration”, which includes classrooms, advertising and laser light shows.
Previously, CDRH had a restricted definition of SLA lasers. In late 2010, CDRH received an opinion from FDA’s Office of Chief Counsel that apparently re-classifies laser pointers as "surveying, leveling and alignment" lasers. CDRH says these "SLA" lasers tend to be portable, are generally handheld, emit into open space, and have a straight beam. The intent is to classify any handheld laser emitting a straight beam into open space as an SLA laser.
This would then permit CDRH to regulate all SLA lasers -- e.g., all handheld portable lasers -- above 5 milliwatts. This would then require buyers to have a variance to purchase and use the laser. This differs from the past U.S. system where, if a laser over 5 milliwatts is not advertised for pointing or other "demonstration" purposes, then it could be sold unrestricted to anyone, with any power.
The above is LaserPointerSafety.com’s best interpretation of recent CDRH actions. LaserPointerSafety.com does not agree with the new SLA interpretation. More background, and the reasoning behind our disagreement, is on the page FDA authority over laser pointers and handheld lasers.
UPDATE, March 2014:
A 2012 FDA warning letter includes the following: “products that FDA has considered to be SLA products ... include products described as target pointer illuminator aiming, tactical laser illuminator, infrared zoom illuminator, and laser illuminator. Illuminator, alignment, target designation, pointing, or any similar description of a laser product for use in alignment or positioning provides a basis for classification of a laser product as a surveying, leveling, or alignment laser product.” (Thanks to Jess Lambert for bringing this to our attention in March 2014.)
DISCLAIMER: If you need specific advice about a laser or a use, you should check with FDA/CDRH and/or a qualified, experienced laser safety consultant.