Garoq
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- Joined
- Aug 27, 2010
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Thank you for your kind comments, Larry.
I have a lot to say about the FDA situation but I cannot go into all the details yet. They certainly seem to be taking a keen interest in what is going on in the laser community. And what they call a regulated "laser product" may surprise you. It includes things as innocuous as any host that is specifically promoted to house a laser. It doesn't even need to include a driver circuit.
There are also some misconceptions out there, one is that by simply adding the "safety features" to a class 4 laser and getting an "accession number" you make it legal in the eyes of the FDA. It does not...in fact they have stated to us that NO hand held class 4 laser is legal to sell in the US.
The FDA asserts that virtually all handheld lasers are SLA lasers. Under 21CFR 1040.11(b)
CFR - Code of Federal Regulations Title 21
SLA lasers are limited to class IIIa (<5mW).
I have a lot to say about the FDA situation but I cannot go into all the details yet. They certainly seem to be taking a keen interest in what is going on in the laser community. And what they call a regulated "laser product" may surprise you. It includes things as innocuous as any host that is specifically promoted to house a laser. It doesn't even need to include a driver circuit.
There are also some misconceptions out there, one is that by simply adding the "safety features" to a class 4 laser and getting an "accession number" you make it legal in the eyes of the FDA. It does not...in fact they have stated to us that NO hand held class 4 laser is legal to sell in the US.
The FDA asserts that virtually all handheld lasers are SLA lasers. Under 21CFR 1040.11(b)
CFR - Code of Federal Regulations Title 21
SLA lasers are limited to class IIIa (<5mW).