FDA Crackdown?

[DZ]

Yeah it looks completely legit to me as well.

they have no idea the wrath that will come down on their heads.

I don't doubt it, where will it stop though? If they mop things up over there, are they gonna start scrutinizing us? Besides, in my opinion, this is suppose to be a free country, if you wanted to own a 20W laser pointer then so be it. Fine/jail the people who use them improperly, don't punish everyone...

[keeperx]

well owning one and selling one are 2 different things..

[Laserman532]

as i said over there...there are no loopholes in the phrase..."entered into commerce" Technically you cant even give it away because you are technically manufacturing and "entering it into commerce"

[Lasernerd]

That is real!
No doubt looks just like my paperwork except my variance paperwork has the eagle papermark

[mixedgas]

Just read this on another forum, rather interesting. This is certainly not a letter any of us would want to receive in the mail.

http://laserpointerforums.com/laser_...ad.php?t=40101

And the folks giving him a hard time for beliving it are idiots. That is CDRH/FDA letterhead, I have a few samples of it myself.

I sense a crackdown. Meredith Instruments is making Ebay buyers sign a OEM agreement.

I'm willing to be bet Homeland and FAA are starting to get very angry about loose lasers and CDRH is feeling some pressure.

Oh, and those of you who sell galvos, better make it very clear your selling oem galvo pairs and NOT complete projectors or usable systems on your websites.

I once met a guy who got busted for selling flyback based HENE laser power supply kits, by the time his lawyer made 20,000$ for handling the case against his company, the fine was reduced to 8,000$ , and that was mid 90s. One wonders if selling 10 or 100 kits at 25.00 A kit was worth it.

Somebody go tell that guy that FDA hands cases off to very real US Attorney types. Also tell him to call some one at say, Laser Compliance Inc.
Or one of the other laser safety firms. Just Joe Ordinary Lawyer is probably not gonna be enough.

Here we go.... ready for fireworks!


Steve

[sugeek]

Here is the letter for the lazy peeps like me... Hotlinked.

[QUAZAR]

Those kids over there get really irate when someone tells them the truth.

Tiz their own fault if they dont take the advice.

[keeperx]

well i think he should just call Dan and let him know whats up.. see if he is actually doing something wrong and go from there.

[Laserman532]

well i think he should just call Dan and let him know whats up.. see if he is actually doing something wrong and go from there.

you obviously havent read the whole thread

[mixedgas]

Paragraph 2 "Specifically, these products are described as Blu-Ray and Red Lasers and Laser Kits. These laser products are surveying, leveling and alignment laser products"

Not being funny, but did i miss something. Since when has blu-ray ever been used for surveying!.

FDA is telling him since he didn't register his products, they are putting him in the product class they think he should be in. Selling a overpowered alignment product without quality control paper work makes it more of a open and shut case. Since he didn't register as a demo laser product, they get to pick the violation and device classification. OUCH!

And btw, since the diode can lase, its a complete product even as a raw diode chip.

There is no getting out on a technicality.

A FDA regional EOS will/could visit his facility next, and has a federal badge. If the FDA feels its needed, a US Attorney will hand them a warrent and the FDA will take the local sheriff if needed. If he was really unlucky, a EOS bought the product and documented it.

Steve