Im LOVIN this!!!
http://www.fda.gov/ICECI/Enforcement.../ucm234938.htm
Seems as if the fit might start hittin the shan!
-Marc
Im LOVIN this!!!
http://www.fda.gov/ICECI/Enforcement.../ucm234938.htm
Seems as if the fit might start hittin the shan!
-Marc
ILDA- U.S. Laser Regulatory Committee
Authorized Dealer for:
- Pangolin Laser Software and Hardware
- KVANT Laser Modules & Laser Systems
- X-Laser USA
- CNI Lasers
- Cambridge Technology & Eye Magic Professional Scanning Systems
FDA/CDRH Certified Professional LuminanceRGB Laser Light Show Systems
It's dated Nov 03, 2010 - they must have ignored it?
/Thomas
They have been served warning letters as far back as 2006! Shows US gov. has little control over imports.
Then you don't know about them taking the Wicked pointers out of the boxes and sending the empty boxes on to the customers? Guess what! They have been going after the Wicked 445s at the ports of entry.
I agree, little control. But they are trying with Mr Liu aka whatever his name really is.
Steve
Last edited by mixedgas; 01-25-2011 at 15:25.
I would be curious to know what percentage they actually catch? Don't think the gov has enough man power to check every DHL, FEDEX, or UPS envelope.
Don't need-to.. Once you X and with the CDRH enough-times (like Wanton has...) you get put on the 'Red List' for 'Special People', where they can detain your cookies under 'DWPE' (Detention Without Physical Examination)-provisions...
http://www.accessdata.fda.gov/cms_ia...alert_254.html
In other words, they don't have-to inspect the packages... if *ANY* package arrives from "Energy Technology Development Ltd. / Wicked", etc, (or any of the other 'aliases' they prolly try and use ) and 'pops-up on the grid' during import scan, they can, indeed, 'DWPE' (...the 'ownice for doing' falls-on Customs and the shippers) which likely-means, you're SOL...
Sadly, this 'dragnet' process isn't 100%-efficient, but, hey - it's a 'start'...
Interesting, too, this little 'provision' of the law: (...clipped from the Nov '10 letter...)
"Persons who violate section 538 of the Act are subject to civil penalties of up to $1,100 per violation and up to a maximum penalty of $355,000 without further notification by the FDA. In cases where a foreign manufacturer fails to respond, penalties may be imposed upon importers."
, indeed...
I'd say, you wanna own a Class IV pointer? Take an exam, with a 'live interview-portion' detailing the 'legitimate-use' you have planned for it (...and: "uhhmmm..." / "Starpointing!" doesn't count...) ...pass, and it's yours... Oh, AND you need your CDRH Variance to use it, in public, just-like any-other light-show device... Otherwise, much like we don't just 'pass-out' drivers licenses, etc w/o the person *demoing* at least some measure of responsability, knowledge of the law / safety whys and wherefores, etc, I'd say FAIL....that person doesn't deserve to be allowed to buy one / own one...
But yes, I know - 'where's the $5 Billion going to come-from to do that?!'... yeah, well, whattaya gonna do... We gotta at least *try*...
peas
j
....and armed only with his trusty 21 Zorgawatt KTiOPO4...
Holy shit!
That's the strongest-worded letter I've ever read from the CDRH... Maybe they finally grew a pair and are trying to do something for a change!
Wonder what Wicked has been doing since November?
Adam