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Clinical Studies & FDA 510(k) Clearance Process

Clinical Studies

HairMax has invested in more research and clinical studies on light energy for hair growth than any other company. Seven clinical studies with 460 men and women have been completed conclusively proving it works safely and effectively – with NO worrisome side effects.These studies were conducted by leading scientists and physicians in the field of hair loss. Our studies were conducted at top medical research centers including the Cleveland Clinic, the University of Miami and University of Minnesota.

The Result?

90% success rate, 129 additional new hairs per in. sq. , 8 FDA Clearances*. 6 published peer reviewed articles.

  • Six of these studies were designed as multi-centered, double-blind and randomized control device

  • Designed to provide support of 510(k) submissions to the FDA – Major factor in granting of Clearances

  • Approved by an IRB (Independent Review Board)

  • Complied with GCP (Good Clinical Practices) guidelines

  • Monitored by a CRO (Contract Research Organization)

In 2006, after years of extensive research and randomized clinical studies, Lexington International submitted the results of its initial six-month, multi-center placebo controlled clinical trial to the FDA. The data from the trial demonstrated that 93% of the male subjects had highly statistical improvement in hair counts after 26 weeks of treatment. Learn more about our Clinical Studies 

FDA Clearance

Based on part of the results of this study, the FDA granted initial marketing clearance for the treatment of androgenetic alopecia, (pattern hair loss)* and promotion of hair growth in males in 2007. In 2011, additional clinical studies by HairMax were submitted to the FDA and clearance was granted for females with androgenetic alopecia, (pattern hair loss)*.We've continued to innovate and to achieve additional FDA Clearances for all our devices, including RegrowMD 272 Laser Cap.

June 2018

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

September 2011

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

August 2011

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

May 2011

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).

November 2009 & April 2011

HairMax received FDA clearances on new LaserComb models.

January 2007 - First Groundbreaking FDA Clearance

The HairMax LaserComb® was granted the FIRST 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

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

All HairMax FDA 510(k) Clearances 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/ RegrowMD to treat your hair loss, because of the extensive clinical research and validation.

© 2018 RegrowMD by HairMax. Lexington International, LLC.


*The HairMax Laser 272 is indicated to promote hair growth in males with androgentic alopecia who have Norwood-Hamilton Classifications of Ila - V, or females with androgenetic alopecia who have Ludwig-Savin Classifications I - II or Frontal and for both with Fitzpatrick Skin Phototypes I- IV.
 † 20% Restocking fee applies. ‡ Success rate is based on clinical studies.