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FrozenGate by Avery

closed

Interesting. How many FDA letters does this now make in a matter of just 3 months?
All of them have been fake thus far, but yours does seem legit.

Bummer
 





OR you can simply state that you didnt sell any and your not going to sell any , and that's that..

simple.

Of course you can sell NOT out of your website on lpf..
 
Mohrenberg said:
so.....would it be legal for me to sell completely assembled lasers, the modules being similair to green modules (with a fully open driver) with an adjustable pot?

basicly the pot would be set so that it's putting out either no current, or enough to give it something UNDER 5mW.....with a max current of the driver being the desired current for that build...so the customer would have to adjust the pot, thus modifying the laser themselves?
Click to expand...
That would probably be legal as long as you state that they are 'officially <5mw' on your website. The problem is that you would still need to REGISTER them with the FDA even if they are legal.

I'm no lawyer though..
 
Arenared said:
OR you can simply state that you didnt sell any and your not going to sell any , and that's that..

simple.

Of course you can sell NOT out of your website on lpf..
Click to expand...

Are you kidding me? If he states none, they will drop a subpoena on him so quick and seize all documents, bank records, paypal records, and whatever they think they need. Now is not the time to lie. Now is the time to talk to the FDA and get it worked out. They will be very accommodating if you want to correct the issues. Don't give them any reason to make an example out of you.

Call the FDA and verify the letter.
Prepare a response to the required information with a lawyer if you have one.
Respond to the FDA.
Await their determination.
 
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mikeeey said:
?
I'm not giving "legal advice"... =/
Click to expand...

You gave advice on what kinds of lasers could legally be sold, saying that an "adjustable" 5mW laser could be sold without meeting standards.

How is that not legal advice?
 
FrothyChimp said:
Are you kidding me? If he states none, they will drop a subpoena on him so quick and seize all documents, bank records, paypal records, and whatever they think they need. Now is not the time to lie. Now is the time to talk to the FDA and get it worked out. They will be very accommodating if you want to correct the issues. Don't give them any reason to make an example out of you.

Call the FDA and verify the letter.
Prepare a response to the required information with a lawyer if you have one.
Respond to the FDA.
Await their determination.
Click to expand...

I dont think its that serious, they state in their letter that he is advertising , blah blah..

I think they want a cease and desist letter from him telling them he is not selling ..
 
If he sold completed modules, ready to install into a host that he sells separately, would he still have to have the modules registered with the FDA?
 
pullbangdead said:
You gave advice on what kinds of lasers could legally be sold, saying that an "adjustable" 5mW laser could be sold without meeting standards.

How is that not legal advice?
Click to expand...
it was more of Agreeing with the post before mine, just restating it basically. Keep in mind I did say maybe.
It didn't even need to be a completed 5mW laser. Module, and driver set to 5mW, idk.

What about the 5mW dealextreme lasers? They meet the standards, but what is the difference?
 
Ya know I can't believe a single individual has even wondered at the validity of the FDA's inquiry's as of late. They made it VERY clear by cracking down on paypal and ebay, subsequently preventing Dealextreme and Kaidomian from selling to the U.S., that they were not going to allow illegal lasers in the U.S. any longer. So we are hobbyists. What we sell is still Illegal. There is no way around it. You step up to the plate and pay the piper. It's a risk we were all taking in selling lasers that exceeded 5mw.

I feel for you Mohrenberg. It is a horrible thing to have this happen.

spyrorocks said:
I don't believe OEM components need to be registered, do they?
Click to expand...

Yes even modules or OEM components need to be registered as a variant. Something that does NOT comply.
 
Wow, tough man tough.

Like someone already said before me, this is the time to come clean with everything that they ask, lying to the FDA and twisting facts at this point is very ill advised. Hopefully they will see that you are trying to cooperate.

Keep us posted, and best wishes that you get this ordeal straightened out.
 
Did you see Robert Doyle's handle...

"Division of Mammography Quality and Radiation programs"...

"Office of Communication, Education, and Radiation Programs"...

"Center for devices and Radiological Health"...

The only one that bothers me is the last one...
I don't think your lasers are used for Mammography or Communication...

Jerry
 
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