World-class standards certified by FDA

HairMax® is changing the way men and women around the world treat hair loss with the world's first FDA-cleared laser phototherapy technology for at-home use to treat hair loss and stimulate hair growth.*

And it doesn't stop there — to date, the HairMax® has received a total of eight FDA clearances , the most of any laser hair therapy device.

World-class production quality

Every step of HairMax® production is subject to strict quality control standards.
and has been certified by world-class standard systems, including:

• ISO 13485:2016 – Quality management systems for medical devices
  

• MDSAP Certified Company – Certified by the International Medical Device Single Audit Program (MDSP).
  

• USFDA GMP Compliance – Complies with the quality requirements of the US Food and Drug Administration (21 CFR Part 820).
  

•  Emergo Europe – HairMax® is regulated and certified in Europe.
  

The trust path is FDA approved.

• June 2018 – HairMax® Laser 272 PowerFlex Cap and RegrowMD Laser Cap
  It is FDA approved for the treatment of genetic hair loss in both men and women.
  

• December 2014 – HairMax® LaserBand
  It is FDA approved for the treatment of genetic hair loss in both men and women.
  

• September 2011 – HairMax® LaserComb
  Expanded FDA approval to cover the treatment of female hair loss across multiple generations
  

• August 2011 – HairMax®
  First FDA-cleared dual wavelength laser device to treat genetic hair loss.
  

• May 2011 – HairMax® LaserComb
  It received FDA approval for the first time as a medical laser device for home use to treat female pattern hair loss.
  

• November 2009 and April 2011 – HairMax®
  Additional FDA approval received for new version of LaserComb device
  

January 2007 – HairMax® LaserComb
FDA-cleared as the world's first medical laser device for home use in the treatment of male pattern hair loss.