The FDA Doesn’t Approve of the way Wicked Lasers Is Making Their Lasers [Lasers]

http://cache.gawkerassets.com/assets/images/4/2010/09/500x_spyder.jpg After Wicked Lasers wowed the net with their Spyder III super laser, many shoppers who actually ordered ‘em found themselves high, dry, and laserless. Now, another bummer: the FDA has officially decreed that Wicked Lasers’ manufacturing process isn’t any good.

In a letter issued at first of last month , the FDA says that it ” disapproves the quality controls and testing program for all laser products including, but not limited to model families Core, Spyder, Executive, Evolution, Elite, E2, E3, S3 and Pulsar” produced by Wicked Lasers. It gave the company 15 days to either refute the claim, ask for exemption, or detail its corrective action, in addition as requiring WL to produce an inventory of lasers already sold, a new overview of their qc procedures, and a product report for all US-bound laser models. Presumably Wicked Lasers has already submitted these documents to the FDA to study.

On their site, Wicked Lasers says they’ve got their FDA compliance policy on lock , though presumably all that checked out before FDA found problems with their manufacturing.

In any event, while it’s nice that the FDA is ensuring Wicked Lasers’ stuff is safe, it’d be great if someone was making certain there was stuff to send to customers inside the first place. In the event you’re one of the most customers who’s still having trouble getting a lock to your laser, shoot me an email and I’ll try and verify they help geT your order on course.
[ FDA - Thanks Michael]

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This post is tagged: compliance policy, corrective action, laser products, manufacturing process, qc procedures, quality controls, wicked lasers