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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).
 





Joined
Oct 6, 2012
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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).

Hi Gary,
As you're able to, I would love to hear about what's going on with the FDA. I can picture three things; One is your typical political group-think where committees or special meetings take place and for any of you who have worked in that kind of industry (me - gov't/mil scientist/engineer my entire adult life), there is always one who will find the worst possible thing which can happen and then it gets amplified throughout the attendees like the way 'war stories' are told, two (which should be part of one) is since terrorism is on peoples' minds and many aircraft have been lit up by toy lasers, they assume the worst and write regulations from there (one of my big soap boxes. Like prank firecrackers by kids in the old days were reported as such - nowadays, they're called 'bombs' in the news and I'm sure everyone gets involved. My third and last point is that I have always seen bureaucracies in the light of my bio background. They're like organisms which want to grow and need to feed. In order to feed, a bureaucracy must validate itself by producing lots of important rules and regulations. I see you caught in this for sure.
 
Joined
Apr 2, 2009
Messages
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This SPAMMER/CLOWN 'Salvator''has me so ticked off so much that I accidently + repped him-
he is now spamming via PM and VM and attempting to steal buyers from a banner advertizer.. JETLASER & Gray--

Can you believe he prolly kisses his mom with that dirty mouth--

LPF is not for him..
seven day ban will not work-HOpe a mod checked his IP-
IF HE HAS PMed/spammed you please report this to a mod-
 
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Garoq

0
Joined
Aug 27, 2010
Messages
1,525
Points
83
Thank for the update Hak...

I was recently scammed by a couple of guys in Indonesia, they are using stolen credit card numbers to barrage the store with orders hoping one will go through, and in fact a couple have. :(
 




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