FDA 510(k) is a premarket notification to proof the efficacy of a medical device. Hand-in-hand with our commitment to customer satisfaction, we have pursued costly clinical trials to conclusively prove that the HairMax LaserComb is a safe and effective hair loss treatment for both men and women.
There have now been a total of 6 FDA Clearances of the HairMax LaserComb for marketing since 2007 which means that all data submitted was subject to intense scrutiny and review before being cleared. When a company receives this clearance, there are stringent rules and high standards put into place covering all aspects of manufacturing and quality control.
The HairMax LaserComb is the first and only Laser PhotoTherapy device that has been reviewed by the FDA and cleared for marketing four times for the treatment of androgenetic alopecia (pattern hair loss) in both males and females. Our clinical data was submitted to the FDA and rigorously reviewed for all 510(k) submissions.
HairMax
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— The HairMax LaserBand is the only home-use FDA-Cleared laser photo therapy device clinically proven to treat hair loss and promote hair growth in both men and women. — The light-weight, flexible band design adjusts to fit most head sizes for a very comfortable treatment. — The patented soft touch teeth part your hair during…
— The HairMax LaserBand is the only home-use FDA-Cleared laser photo therapy device clinically proven to treat hair loss and promote hair growth in both men and women — The new flexible band design incorporates patented soft touch teeth to part your hair during treatment and maximize laser light delivery to your follicles. — Working…
—Targeted Treatment or Full Scalp Coverage —The HairMax LaserComb is the only home-use FDA-Cleared laser photo therapy device clinically proven to treat hair loss and promote hair growth in both men and women —This targeted laser treatment delivers nourishing laser light energy directly to your hair follicles to reverse the thinning process and regrow your…
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