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FDA CLEARANCES

HairMax has revolutionized the way men and women around the world treat their hair loss. HairMax was granted the FIRST FDA clearance as a laser phototherapy device for home use to treat hair loss and promote of hair growth*. We didn’t stop with just one FDA Clearance, HairMax devices have been granted an unprecedented total of 8 FDA Clearances to date.

June
2018

RegrowMD Laser 272 laser cap

RegrowMD Laser 272 laser cap was granted FDA Clearance for the treatment of androgenetic alopecia* (pattern hair loss) in both men and women. The device design utilizes the unique BioLight Comfort feature which incorporates 272 laser diodes within a flexible, lightweight inner liner to optimally provide a direct flow of light energy to reach the scalp for optimal results.

December
2014

The HairMax® LaserBand

The HairMax® LaserBand was granted FDA Clearance for the treatment of androgenetic alopecia* (pattern hair loss) in both men and women.

September
2011

HairMax LaserComb

HairMax LaserComb expanding its Clearances to multiple devices to treat Female Hair Loss.

August
2011

HairMax LaserComb

HairMax LaserComb continues to demonstrate leadership in clinical research and FDA Clearances.

May
2011

The HairMax LaserComb®

The HairMax LaserComb® was granted the FIRST FDA Clearance as a medical laser device for home use for the treatment of hair loss in females with androgenetic alopecia*(pattern baldness).

April
2011

HairMax received FDA clearances on new LaserComb models.

November
2009

HairMax received FDA clearances on new LaserComb models.

January
2007

The HairMax LaserComb®

The HairMax LaserComb® was granted the FIRST EVER FDA Clearance as a medical laser device for home use for the treatment of hair loss in males with androgenetic alopecia*(pattern baldness).

HairMax Laser Devices, FDA 510(k) Clearances as Medical Devices Are Based Both Safety and Efficacy.

There have now been a total of 8 FDA Clearances of HairMax Laser devices for marketing, all of which required the submission of not only safety, but also effectiveness based on scientifically designed clinical research studies.

These submissions and all of our FDA Clearances, means that all data submitted was subject to intense scrutiny and review. When a company receives FDA Clearance, there are stringent rules and high standards put into place covering all aspects of manufacturing and quality control. To put it simply, we know there are countless products on the market that promise to re-grow hair, but end up having little or no effectiveness. You can trust HairMax to treat your hair loss, because of the extensive clinical research. Our clinical studies results have been conducted by top physicians in hair loss and study results have been published in 6 peer review medical journals, this makes HairMax the only laser devices for hair loss on the market with such unsurpassed substantial validation.