Home | News | Find a Doctor | Ask a Question | Free

On what basis do they give FDA approval


#1

all these products like laser comb , finasteride … etc
how come they get the FDA approval if they don’t work, anyone can explain that?


#2

The FDA is the best regulatory agency that money can buy.

Okay, seriously, they’re useful to screen out stuff that poses an egregious danger to the user. And they’re useful to test for some amount of efficacy IF the results are touted as such. But they can be fudged with money from the drug company.

I think the lasercomb deal is just tested and stated not to do any harm, not for actual growth efficacy. (The devil is really in the fine print about this stuff sometimes.)

Regardless of the advertising and crap, the online MPB community had identified the difference between Fin & Minox & Niz’s FDA approval and the lasercomb’s FDA “approval” a long time ago. Just read up on the sites that aren’t selling something and you usually can find out this kind of stuff.


#3

A number of products using low-energy laser light beams have been marketed for hair growth. They are available without a prescription and are usually sold directly over the Internet or through late-night infomercials. Most are packaged like a hairbrush or comb which shines red light directly on the scalp while it is used to comb through the hair. Only one such device, called the HairMax LaserComb (Lexington International, LLC, Boca Raton, FL), has obtained 510K FDA approval for use as a medical device. We explain to patients that the 510K status simply demonstrates safety rather than actual efficacy.

Ref:
Medical treatments for male and female pattern hair loss
Journal of the American Academy of Dermatology - Volume 59, Issue 4 (October 2008)