FDA 510(k) is a premarket notification to proof the efficacy of a medical device. Hand-in-hand with our commitment to customer satisfaction, we have pursued costly clinical trials to conclusively prove that the HairMax LaserComb is a safe and effective hair loss treatment for both men and women.
There have now been a total of 6 FDA Clearances of the HairMax LaserComb for marketing since 2007 which means that all data submitted was subject to intense scrutiny and review before being cleared. When a company receives this clearance, there are stringent rules and high standards put into place covering all aspects of manufacturing and quality control.
The HairMax LaserComb is the first and only Laser PhotoTherapy device that has been reviewed by the FDA and cleared for marketing four times for the treatment of androgenetic alopecia (pattern hair loss) in both males and females. Our clinical data was submitted to the FDA and rigorously reviewed for all 510(k) submissions.