HairMax LaserComb Products Win FDA Clearance

HairMax LaserComb Products Win FDA Clearance

Lexington International, manufacturer and developer of advanced medical laser devices to treat hair loss and scalp disorders, announced it has received Class II FDA 510(k) #K112524 Marketing Clearance for two new models of the HairMax LaserComb.

HairMax LaserComb is a set of laser phototherapy medical devices used for the treatment of hereditary hair loss in women. HairMax LaserComb cordless models are available as the HairMax Advanced 7, the HairMax Lux 9, and the HairMax Professional 12.

Over 30 million women in the United States suffer from hereditary hair loss. Until recently, when the HairMax Lux 9 was initially FDA Cleared for marketing for treatment of females, there had been only one FDA approved drug for treating this condition in women.

The latest FDA clearance expands the HairMax treatment options to their HairMax LaserComb models, offering first-line treatment for hereditary hair loss in men and women. This is the fourth FDA 510(k) Clearance for marketing granted to Lexington International this year, according to company officials.

"This recent FDA Clearance means that the HairMax LaserComb with its patented technology and state of the art design, now solidifies the position of Lexington as the world-wide leader in the treatment of hair loss," said Randy Veliky, Lexington COO, in a statement. "No other company marketing a device of its kind for hair loss matches the breadth, scope, and depth of our product line."

The HairMax Advanced 7, Lux9, and the Professional 12 models are indicated to treat Androgenetic Alopecia. These products are designed to 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.

The treatment is simple with HairMax. It lasts just 9-15 minutes per day, three times per week. Results will be visible in as little as 12 weeks, the company claims. The product is found to be safe to use. No side effects have been reported from the use of HairMax. Says a satisfied customer of HairMax, "It got to the point that I wasn’t going out much anymore. I noticed that when I spoke to my relatives and friends they weren’t looking directly at me – they were looking at my hairline and that made me feel even more self-conscious about my hair loss." And, "HairMax has rejuvenated my hair growth, my self-esteem and my confidence."

In four double-blind clinical studies on the treatment of androgenetic alopecia (hereditary hair loss) in both men and women over 93 percent of subjects in the HairMax LaserComb groups experienced hair growth at 6 months. These results were consistent in all studies, demonstrating that the results with the HairMax are reproducible and predictable.

Since 2001, Lexington has completed a total of seven clinical studies with 460 subjects. All of the studies have conclusively proven that the HairMax LaserComb family of products is efficacious and safe as first line therapy for appropriate classes of hereditary hair loss.

"We have spent 11 years of R & D, innovation, and the completion of seven clinical studies to bring these innovative products to market," said David Michaels, managing director of Lexington, in a statement. "This recent FDA marketing Clearance brings to fruition our goal of offering a complete line of laser phototherapy products for people who are suffering from hereditary hair loss."

"Our challenge now is not how to get there, but how to assure that we get this information about the HairMax out to the millions of people suffering from this devastating condition," Michaels added.

In a recent article, Kim Painter explains five ways to prevent hair loss in men and women. They are: Don’t smoke, wear a hat, watch what you drink, stay happily married, and go easy on braids and weaves.


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