HAIRMAX LASERCOMB

Getting the Record Straight - Marketing of Laser Photo Therapy Devices Despite claims made by other companies and certain Physicians, Lexington International, LLC manufactures the ‘only’ medical device that has been Cleared for Marketing by the FDA and is clinically proven to “Promote Hair Growth.”



Lexington International, LLC, the developers of the HairMax LaserComb, is the only company that has, over decades of research and development, invested in and performed clinical research. We have brought to the market a hand-held laser device that is backed by sound science and is clinically proven to grow hair in male patients with androgenic alopecia*. To date, we are the ONLY company that has taken the time to conduct clinical studies to prove efficacy of the device and to submit them to the FDA in a formal 510(k) filing. This clinical study proving efficacy was pivotal in the granting of the clearance to market the HairMax LaserComb for certain classes of male pattern baldness*.

All other hand-held laser photo therapy devices currently marketed at this time, do NOT have FDA clearance to market their devices and they are marketed as cosmetic devices.

The HairMax LaserComb is a user-friendly hand-held Class 3R laser photo therapy device that contains a single laser module which emulates 9 beams of laser energy. The patented ‘teeth’ component is designed to part the user’s hair to ensure an unobstructed path for laser delivery to the scalp at the base of the hair follicle. All other marketed products at this time do NOT offer this hair patented hair parting mechanism. Since these devices do not have this device as an integral part of their devices, it means that a lot of the laser energy is blocked by the hair from reaching the skin surface of the scalp.

With hair parting teeth	Without hair parting teeth
View of the Hair Parting Mechanism in Action. This is a simulated view from the scalp facing towards the path of the LaserComb. As you can see, without hair parting teeth, the majority of the laser energy is blocked by the hair itself.

FDA CLEARANCE TO MARKET IS NOT AN INDUSTRY CLEARANCE
IT IS ONLY SPECIFIC TO THE HAIRMAX LASERCOMB PREMIUM

The FDA generally ‘Approves’ drugs and ‘Clears’ devices for marketing with an ‘indication of use’. Many of the hand-held lasers on the market claim that they can achieve comparable results to the HairMax LaserComb, but without the patented hair parting ‘teeth’ of the HairMax LaserComb, the laser energy of their devices may not be able to reach the scalp since they do not part the hair on application.

As a consumer, we suggest that you educate yourself thoroughly before making a purchase or utilizing a hand-held laser device for hair growth. It is important to remember that the HairMax LaserComb is presently the only device on the market with proven efficacy, has gone through the rigorous process of gaining FDA clearance to market, and is subject to stringent manufacturing regulations as part of this clearance. When considering the purchase of any other device, consider the fact that the results of the HairMax LaserComb are proven and that ALL other laser products now on the market, cannot make this claim.

Remember! All hand-held laser photo therapy devices are NOT the same and that no other presently marketed device has the clinically proven results of the HairMax LaserComb nor the patented device that maximizes laser energy delivery to the scalp.

* The HairMax LaserComb is cleared for marketing by the FDA for The Promotion of Hair Growth in males with Androgenetic Alopecia who have Norwood Hamilton Classifications of IIa-V and Fitzpatrick Skin Types I to IV