FDA clears laser-based comb to combat hair loss

The FDA has just cleared two new phototherapy devices manufactured by Lexington International under the brand HairMax for the treatment of hereditary hair loss.

The company says its technology parts the hair to ensure that laser light reaches the scalp and stimulates the hair follicles, as opposed to so-called top-of-hair devices like helmets or caps.

The new HairMax products require three minutes of treatment time, the company said in a statement. Introduced in 2001, the HairMax LaserComb can be used in the home and has been the subject of 7 clinical trials with 460 subjects, according to the release.

David Michaels, Lexington managing director

"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," said David Michaels, managing director of Lexington, in a statement.

According to the company's website, there are three models of HairMax LaserCombs already on the market, with treatment times ranging from 8 to 15 minutes, and at price points ranging from $295 to $545. The products are indicated for use by both genders.

The new products will hit the market in the first quarter of 2015, according to the release. With the recent development, the Lexington now has 7 FDA clearances to its name, with the first one occurring in 2007, according to the FDA 510(k) database.

HairMax products are available in more than 165 countries.

- read the release
- here's the HairMax website

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