New and Innovative Hair Loss Treatment Devices from HairMax Receives FDA Clearance
Posted by Fran Dubsky

Press Release (PDF)

Lexington Int'l is pleased to announce that it has received FDA 510K Marketing Clearance for 2 new HairMax enhanced, hands-free laser phototherapy devices. These new innovative devices, expand and add versatility to our family of laser phototherapy hair growth medical devices, for treatment of men and women suffering from pattern baldness.

Boca Raton,FL (PRWEB) December 12, 2014

Lexington Int’l pioneered the home use laser phototherapy treatment of hereditary hair loss with the introduction of the HairMax LaserComb® in 2001 and is now a world-wide leader in products for the treatment of hair loss. We are pleased to announce that we have received FDA 510K marketing Clearance for the enhanced, hands-free HairMax for the treatment of hair loss in men and women. (FDA 510K 142573 - HairMax 41 & 82).

As background, it is a well-known fact that hair acts as a photoprotectant, which helps block light from reaching the scalp. Recognizing this obstacle, the company has developed and marketed as a core technology, laser phototherapy devices that part the hair to allow for optimal delivery of the laser light to the scalp to better stimulate the hair follicles. Other marketed laser phototherapy devices that are designed as helmets or caps only deliver laser energy to the top of the hair. Because of this design, there may be blockage of delivery of light energy to the scalp, which diminishes treatment results and expands treatment time. Therefore, these new HairMax devices offer a distinct advantage over other hands-free ‘top-of-hair’ laser phototherapy treatment products for hair loss.

We believe that the new HairMax is a major step forward in the treatment of hair loss because of this technology, and will prove to be much more effective than any other device on the market. The new HairMax will also offer greater convenience as only less than 3 minutes of treatment time is required each time it is used, versus required treatment times of around 20 minutes for hands-free ‘top-of-hair’ devices.

As the pioneer in the marketing of home-use laser phototherapy devices for hair loss, our laser phototherapy devices have a number of distinct advantages over other marketed products of its kind:

  • The company is the only one to have received 7 FDA Clearances
  • The HairMax devices are indicated for treatment of both Men and Women
  • The HairMax LaserComb has been the subject 7 clinical trials with 460 subjects, which have consistently proven the efficacy and safety of these devices.
  • The only company to have the results of our clinical trials published in 4 peer review medical journals
  • The new HairMax along with the other marketed laser phototherapy devices, will provide a full line of versatile devices to choose from.

Lexington will introduce the new HairMax in the first quarter of 2015. This new device will be joining and expanding the family of other laser phototherapy products marketed by the company. It will further solidify the position of Lexington as the world-wide leader and innovator in this market segment.

Mr. David Michaels, Managing Director of Lexington stated: “We have devoted a considerable amount of developmental time in designing the new enhanced hands-free HairMax with a world renowned Industrial Design Group in Italy. We believe that the these new devices are the most efficacious hands-free design for offering ease of compliance, to enhance the user experience." Mr. Michaels also said: "We are pleased to receive FDA Clearance for the new enhanced hands-free HairMax, which will expand our line of innovative, effective, and technologically advanced treatments for hair loss.”

About Lexington International, LLC

Based in Boca Raton, Lexington Int’l is a pioneer in the development of advanced hair loss treatments and laser hair growth products. The HairMax LaserComb is the only laser phototherapy medical device with 7 FDA Clearances for the treatment of hereditary hair loss in both men and women. The HairMax is also the only laser phototherapy device to have the results of 6 clinical studies proving efficacy and safety of the device, published in four peer-review medical journals. Since 2001, in over 165 countries worldwide, Lexington Int’l., LLC has helped hundreds of thousands of individuals to treat their hair loss and improve the condition of their hair.

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