Just a couple weeks ago, the FDA published a warning letter sent to the makers of the LaserComb (see here). Now, a reader sent in a new find on the FDA website — a warning letter to another laser company that shows they are selling a product or service that is in violation of the law. The letter starts off…
Dear Mr. Gaunitz :
The Food and Drug Administration (FDA) has learned that your firm is marketing the THL-1™ Handheld Laser in the United States (U.S.) without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
Another laser, another violation. Read the entire document at the FDA site — here.