The Study That Was Submitted to the FDA Before Approving the LaserComb

I was looking at a site called hairlossadvances.com and on it they show a study that they claim is the actual study that Lexington submitted to the FDA for the lasercomb’s 510k SE clearance.

What I found odd was that the study was completed some 9 months before it was submitted, one of the exclusion criteria for participants was having a buzz cut, (you’d think that having shorter hair would allow more ” nourishing laser light” to penetrate the scalp and provide better results) and the person producing the study claimed that the study wasn’t required by the FDA. Have you seen this study, and if so, what are your thoughts.

I have seen the original study and I have published my opinions on the matter:

• HairMax LaserComb Receives FDA Approval?
• Why Are You Suspicious of the FDA and the LaserComb Now?
• Analyzing the Results of the HairMax Laser Comb

I tend to agree with your astute observations and criticism. This is a subject that I can not fight over. There seems like there is some evidence in the study that it works, but I frankly don’t believe it. It is hard for me to believe that there is almost 100% more growth after a few months. The FDA study is what it is.