Sunetics Laser Gets an FDA Warning

It seems you overlooked yet another laser device maker that was issued a warning letter from the FDA. Apparently the FDA had some problems with the marketing of the Sunetics laser brush. Funny thing is if you read the warning letter (provided in the link below), the FDA acknowledges that they applied for clearance in January of 2008. It’s been over 1 year and they still haven’t received clearance!? Also it’s funny how the Lexington International’s Lasercomb hasn’t yet received clearance for hair growth in women yet that study had to have been completed at least when Lexington received their warning letter back in May. Which leads me to one final question, if 650 nm is the optimal wavelength for hair growth, and all of these laser devices are within that wavelength, how can only one device receive clearance (and only for men)? Almost forgot, here is the link to the Sunetics warning letter page.

FDA – Sunetics International Corporation Warning Letter

The warning letter starts:

“The Food and Drug Administration (FDA) has learned that your firm is marketing the Sunetics Laser Hair Brush and the Laser Skin Brush in the United States (U.S.) without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).”

The letter from the FDA is dated in August, 2008. The FDA usually posts their warning letters publicly months after they send them out. I don’t know if Sunetics got their act together, but I assume that is the case, as their website still shows these products. I know I’ve said it before, but I don’t believe that the low level light therapy works. It is just that simple.