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FDA issues marketing clearance for laser hair-growth device

Washington — The Food and Drug Administration has issued clearance for Lexington International LLC to market its medical laser device, the HairMax LaserComb,® for use in combating hair loss.

As part of the process for acquiring FDA clearance, Lexington conducted a clinical study in four locations in the United States. Results of the study showed that 93 percent of the participants (ages 30-60) experienced an increase in the number of terminal hairs over a six-month period. There were no reports of serious adverse events.

According to its Boca Raton, Fla.-based manufacturer, the HairMax LaserComb® uses a patented technology to part the hair, which allows the laser energy to reach the scalp. A company-issued statement notes that the laser is most effective when it has an unobstructed path directly to the hair follicle.

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