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The Food and Drug Administration (FDA) is an American organization that is responsible for approving nutrition, cosmetics and medication for operation and safety.
HairMax has revolutionized the way men and women around the world can treat their hair loss. HairMax received the first FDA approval as a laser phototherapy device for home use to treat hair loss and promote hair growth. We did not stop with just one FDA approval, but HairMax devices have so far received an unprecedented total of 8 FDA approvals.
December 2018 – The LowLevelLaserTherapy (LLLT) from HairMax is proven to be the best-acting remedy against androgenetic alopecia (hereditary and hormonal hairloss) in both men and women, without any adverse side effects and running costs.
June 2018 – The Laser Cap of RegrowMD Laser 272 received FDA approval for the treatment of androgenetic alopecia (hereditary and hormonal hairloss) in both men and women. The design of the device utilizes the unique BioLight Comfort feature that incorporates 272 laser diodes in a flexible, lightweight inner lining to optimally provide a direct flow of light energy to reach the scalp for optimal results.
September 2011 – HairMax LaserComb extends its plays to multiple devices to treat hairloss in women.
August 2011 – HairMax LaserComb continues to show leadership in clinical research and FDA approval.
May 2011 – The HairMax LaserComb® received the first FDA approval as a medical laser device for home use for the treatment of hair loss in women with androgenetic alopecia (hormonal hairloss).
November 2009 and April 2011 – HairMax received FDA approval for new LaserComb models.
January 2007 – The HairMax LaserComb® received the first FDA approval ever as a medical laser device for home use for the treatment of hairloss in men with androgenetic alopecia * (hereditary hairloss).
From our inception in 2000, it was our mission to develop the highest quality medical devices to treat hair loss at home. We have started an extensive research program designed to receive FDA approvals as medical devices, not just cosmetic devices.
In 2007, after years of research, development and significant investments, a historic event took place, HairMax was granted the first FDA approval as a home laser use laser device to treat hair loss and promote hair growth. We did not stop with just one FDA approval, but HairMax Laser devices have so far received an unprecedented total of 8 FDA approvals. No other laser phototherapy device on the market comes close to this number.
You can be sure that HairMax laser devices are of the highest quality, with the most evidence of consistent and predictable efficiency than any other device on the market. HairMax never leads and follows. From FDA approval to clinical trials to the various available laser device models, we are the global leaders in laser technology for home use.
HairMax: the pioneers of home treatments for hairloss at the lowest level
HairMax was a pioneer in the field of laser phototherapy for hereditary hairloss. HairMax Laser devices have revolutionized the way men and women around the world treat their hairloss. Prior to HairMax, treatment options were limited to oral and topical medicines. There were only two drugs, Propecia® / Finasteride and Rogaine® 5% / minoxidil approved for the treatment of hair loss in men, and only one drug, Rogaine® 2% / minoxidil available for women.
With HairMax laser devices, a safe and effective, non-pharmacological, non-current treatment option is available. Indeed, an article in a peer review medical journal published by leading authorities on hairloss compared the clinical results of HairMax Laser treatments with clinical results of minoxidil and Propecia and found that they were similar. Of the utmost importance, the HairMax Laser devices have an excellent track record, without any harmful side effects ever reported.
HairMax hair loss treatment FDA approval
In 2006, after years of extensive research and random clinical trials, Lexington International submitted the results of its first six-month, multicentre, placebo-controlled clinical trial to the FDA. The data from the trial showed that 93% of the male subjects had a very static improvement in the number of hairs after 6 months of treatment.
Based on a part of the result