There have been a number of posts asking for clarification of the FDA
510(k) clearance process for medical devices.

While the 510(k) process usually involves proving equivalency to other medical devices, some 510(k) filings require filing proof of efficacy through well controlled clinical studies. The filing for the HairMax LaserComb was one of the products that required that proof of efficacy be included in the filing.

The 510(k) process is a rigorous one. In order to provide a more detailed understanding of this process, below is a link to the site: FDA MEDICAL DEVICE CLEARANCE: EFFICACY OR JUST SAFETY? at the HairMax LaserComb web site.