FDA Clearance


In January 2007, the HairMax LaserComb® became the first ever medical laser device to receive FDA marketing clearance for the following indications and uses:


"Promote hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Skin Types I to IV."


The HairMax LaserComb® device is the third product to receive the FDA imprimateur. The device can be used either alone or as an adjunct to other treatments.



Why FDA Efficacy Trials?


Hand-in-hand with Lexington International’s unwavering commitment to customer satisfaction, was the pursuit of this costly clinical efficacy trial to help quantify the effectiveness of the HairMax LaserComb® and to prove that it truly works to promote hair growth in males with Androgenetic Alopecia.


To put it simply, we know about the countless devices on the market that promise to re-grow hair, but end up having little or no effectiveness.


For this reason, we vigorously pursued FDA marketing clearance. With this milestone accomplishment, we can now assure you and your patient of our devices' effectiveness.