Setting the Record Straight - The HairMax is the ONLY home use laser phototherapy device FDA cleared for marketing
 
Learn the facts about the HairMax LaserComb
  • The HairMax is the only home use laser phototherapy device FDA Cleared for marketing
  • The HairMax only home use device clinically proven to “Promote Hair Growth”
  • No other hand held laser phototherapy devices have FDA clearance for marketing 
  • FDA clearance for marketing ONLY applies to the HairMax
  • Patented hair parting mechanism of the HairMax maximizes laser energy delivery to the scalp – no other device has this.

Despite claims made by other companies and certain Physicians, 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 to prove efficacy of the home use phototherpay device and to submit them to the FDA in a formal 510(k) filing.
 
 

No other hand-held laser photo therapy device at this time, have FDA clearance to market their devices. These other devices are as cosmetic devices not medical devices, as is the HairMax LaserComb.
 
FDA Class 2 Clearance HairMax LaserComb
 

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*.  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*.

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. 
 
To date, NO other marketed phototherapy laser devices 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
LaserComb hair parting mechanism in action FDA Cleared Laser comb, Laser Hair Therapy, FDA Cleared for Promotion of Hair Growth, Hair Loss Treatment

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 vs. FDA APPROVAL 
 

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 NO other laser products now on the market, can 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.
 
 
Customer Satisfaction is of Primary Importance
       Clinically Proven to Promote Hair Growth*
       Greater than 90% User Satisfaction Reported
       Patented and Manufactured in the USA
       ISO Quality Assured
       Proud Members of the Better Business Bureau
 

*The HairMax Advanced 7, Lux 9, and the Professional 12 models are indicated to treat Androgenetic Alopecia, and promote hair growth in males who have Norwood Hamilton Classifications of IIa to V and in females who have Ludwig (Savin) I-4, II-1, II-2, or frontal patterns of hair loss and who both have Fitzpatrick Skin Types I to IV.