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warning letters sent out by the FDA

D

dandiele

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Sep 30, 2010
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Hey I was reading on fda website about lasers. decided to search google for anything on fda site about lasers and found a bunch of warning letters sent out to a bunch of companys. there old but its interesting to read some of them.

Search Results: laser pointer site:www.fda.gov/downloads/ICECI/EnforcementActions

also found an alert to customs agents that has the list of all RED LISTED laser sites it says it was published 3/13/12

Import Alert 95-04

or you could do this link to show all import refusals with "laser pointer" in it

https://www.google.com/search?sourc...9607l0l11680l20l20l0l6l6l0l146l1342l11j3l14l0.

none the less i thought some of you might find this interesting to read through briefly.
 





this one was published 3-13-12 not sure if its got any more updates but it seems newer. same alert number though. sorry i posted it in the wrong spot.
 
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Thanks for bringing this up again, and thanks to Madmacmo for pointing out there were changes. It seems another one of our companies has been put up on the list!

skylasersblacklist.jpg


Yep, that's SKYlasers (laserbtb.com) on the list. I actually have a laser en route from them that got through customs and is slated to arive tomorrow. I'm keeping my fingers crossed at this point.
 
That's a big crap sandwich...laserbtb.com was looking to be one of the good ones.

Glenn


Sigurthr said:
Thanks for bringing this up again, and thanks to Madmacmo for pointing out there were changes. It seems another one of our companies has been put up on the list!

skylasersblacklist.jpg


Yep, that's SKYlasers (laserbtb.com) on the list. I actually have a laser en route from them that got through customs and is slated to arive tomorrow. I'm keeping my fingers crossed at this point.
Click to expand...
 
Indeed Glenn, indeed.

My order didn't get held up at all at customs, and DHL called me today at noon to confirm my address (it's odd to have a fraction as the name of your street) and they said it was marked as "flashlight, no battery installed" I said yup that's what I'm expecting. I'm not going to chance ordering from them again, which is a shame because it went through flawless so far. I do NOT like to tempt fate though.

To compound this; I can confirm CNI will NOT ship to the US anymore, I double checked last night. I mean sure, we still have LaserGlow for now, but things are looking a little bleak for DPSS lasers right now. I really hope LG can continue without any problems, even if they can no longer sell to Canadians. If they fall, we're screwed.
 
Laserglow Technologies - Handheld Lasers, Alignment Lasers and Lab / OEM Lasers


• Are your products legal in the USA?

Absolutely! All Laserglow products are 100% LEGAL in the United States unless clearly and specifically stated otherwise on our product pages. Our handheld Class IIIb lasers incorporate a 5-point safety system which includes an aperture shutter, key switch, indicator LED, interlock, and output delay. We have obtained FDA accession numbers for all of our products to be shipped into the United States.

• Are your products FDA certified in the USA?

All of our laser products to be shipped into the United States are certified compliant with FDA regulations. Class IIIb and Class IV (output power >5mW) laser products sold by Laserglow feature the five-point safety system which is required in order for legal import into the United States.

• Will my laser get seized by customs?

We get asked this question a lot so we feel it is important to address this. We can certainly understand the apprehension our customers must have about ordering a product from another country. This is why we do everything we can to ensure that all of our products meet the safety and regulatory requirements of all the countries we ship to. Because our business relies on international customers we cannot afford to take chances. This is why we consult with our customs brokers, who have in-depth knowledge and extensive experience dealing with customs agencies in North America, South America, Europe and Asia, on a regular basis.

We are proud to say that we have a 100% success rate with US Customs clearance because of our strict attention to safety and protocol. We are so sure of our success that we offer a 100% Money Back Guarantee if your purchase cannot be delivered within North America for legal / regulatory reasons.


Glenn
 
Sigurthr said:
Indeed Glenn, indeed.

To compound this; I can confirm CNI will NOT ship to the US anymore, I double checked last night. I mean sure, we still have LaserGlow for now, but things are looking a little bleak for DPSS lasers right now. I really hope LG can continue without any problems, even if they can no longer sell to Canadians. If they fall, we're screwed.
Click to expand...

Are you talking about exotics, or are you including green? Optotronics is in the US.

Also, can't we still get modules?
 
CNI makes more than green dpssfd. I think it is a policy of CNI now to not ship to the US.
 
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Look like the red listing of SKYlasers was from back in March 11, 2011.
 
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