The FDA Does Not Approve of How Wicked Lasers Is Making Their Lasers
After Wicked Lasers wowed the internet with their Spyder III super laser, many customers who actually ordered ‘em found themselves high, dry, and laserless. Now, another bummer: the FDA has officially decreed that Wicked Lasers’ manufacturing process is no good.
In a letter issued at the beginning of last month, the FDA, which is responsible for regulating “radiation emitting devices,” says that it “disapproves the quality control 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, as well as requiring WL to provide a list of lasers already sold, a new overview of their quality control procedures, and a product report for all US-bound laser models. Presumably Wicked Lasers has already submitted these documents to the FDA to review.
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 making sure Wicked Lasers’ stuff is safe, it’d be great if someone was making sure there was stuff to send to customers in the first place. If you’re one of the customers who’s still having trouble getting a lock on your laser, shoot me an email and I’ll try to make sure they help geT your order on track. [FDA - Thanks Michael]
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