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Regulations in the US for system with enclosed class IV laser

Chuie

New member
Joined
Sep 10, 2019
Messages
4
Points
3
If I am selling a device to consumers that makes use of a class IV laser, but the laser is completely enclosed and inaccessible by the user, does that change the requirements that the design needs to meet, or do all consumer goods with class IV lasers need to meet the same requirements?
 



LSRFAQ

0
Joined
May 8, 2009
Messages
1,139
Points
83
21 CFR 1040.1 still applies. All you are doing is technically reducing the hazard to Class I levels, and CLASS IV lasers in consumer goods are tightly regulated by CRH/FDA. Many companies have made the argument that if their beam is totally enclosed they are not marketing a laser device. That is NOT the case under US law.

Steve
 




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