Certifications

HairMax ensures trusted and reliable effectiveness that has proven results. We provide a worldwide solution of the highest quality, with multiple certifications and clearances by medical institutions and international governments.
8 FDA clearances

8 FDA clearances

  • January 2007 – HairMax LaserComb granted the first ever FDA clearance as a home-use medical laser device for treatment of hair loss in males with androgenetic alopecia (pattern baldness).
  • November 2009 & April 2011 – HairMax received FDA clearances on new LaserComb models.
  • May 2011 – HairMax LaserComb granted the first ever FDA clearance as a home-use medical laser device for treatment of hair loss in females with androgenetic alopecia (pattern baldness).
  • August 2011 – HairMax LaserComb continues to demonstrate leadership in clinical research and FDA clearances.
  • September 2011 – HairMax LaserComb expanded its clearances to multiple devices to treat female hair loss.
  • December 2014 – The HairMax LaserBand granted FDA clearance for the treatment of androgenetic alopecia in both men and women.
  • June 2018 – RegrowMD Laser 272 laser cap was granted FDA Clearance for the treatment of androgenetic alopecia in both men and women. The device design utilises 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.
International medical device registrations

International medical device registrations

  • Singapore – Health Sciences Authority approval
  • Australia – TGA approval
  • Brazil – ANVISA registration
  • Canada – Health Canada approval
  • Colombia – INVIMA approval
  • Egypt – Ministry of Health approval
  • European Union – Declaration of Conformity
  • Indonesia – Ministry of Health approval
  • Israel – Ministry of Health approval
  • Russia – Ministry of Healthcare and Social Development
  • Saudi Arabia – SFDA
  • South Korea – KFDA approval
  • Taiwan – FDA
  • Thailand – Thai FDA
  • United Kingdom – ASA approved efficacy claims
  • United States – 7 FDA 501(k) OTC clearances
Quality management systems

Quality management systems

All manufacturing processes are state-of-the-art and ISO Quality Assured.

  • ISO 13485:2003 – Quality System Certification
  • ISO 9001:2008 – Quality System Certification
  • IEC60825-1:2017 – 03 ED2.0
  • USFA Good Manufacturing Practices (GMP) – fully compliant with 21 CFR Part 820, US FDA Quality Systems Regulations