FDA & TGA Clearances
Hairmax® has revolutionized the way men and women around the world treat their hair loss. Hairmax® is TGA certified on at home medical laser devices. 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.
All manufacturing processes are state-of-the-art and ISO Quality Assured.
ISO 13485:2016 – Quality System Certification
MDSAP Certified Company
USFDA Good Manufacturing Practices (GMP) – We are fully compliant with 21 CFR Part 820, US FDA Quality Systems Regulations
Europe * Emergo Europe, 2514 AP The Hague, Netherlands. http://www.EmergoGroup.com
The HairMax® Laser Devices maintain ISO 13485:2016 certification and is audited by:
InterTek Testing Services
70 Codman Hill Road
Boxbourough, MA 01719 USA
Telephone: 1 (978) 929-2100
In 2019, Hairmax®.was granted TGA Approval on Laser
Devices. We hold the title of being TGA Approved as a great achievement, offering piece of mind to all our Australian/New Zealand customers. The Hairmax® LaserComb device has undertaken full quality assurance procedures by the Therapeutic Goods Administration (Medical Devices). Quality assessment was applied at each stage of the medical device’s manufacture to ensure all regulations are of high standard and accuracy. The above certificate is to certify that the manufacturer’s quality management system complies with the relevant provisions set out by the Therapeutic Goods (Medical Devices) Regulations 2002.
- June 2019 – The Hairmax® LaserComb was granted TGA Approval as a medical laser device for home use for the treatment of hair loss (alopecia).
- June 2018 – Hairmax® Laser 272 PowerFlex Cap and RegrowMD Laser Cap were granted FDA Clearance for the treatment of androgenetic alopecia* (pattern hair loss) in both men and women.
- 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 – 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).
From our inception in 2000, our mission has been to develop the highest quality medical devices to treat hair loss at home. We embarked on an extensive research program designed to receive FDA Clearances as medical devices, not simply cosmetic ones. In 2007, after years of research, development and substantial investment, a historic event took place, Hairmax® was granted the first ever 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® Laser devices have been granted an unprecedented total of 8 FDA Clearances to date. No other Laser phototherapy device on the market has anywhere near this number FDA Clearances.
You can be sure that Hairmax® laser devices are of the highest quality, with the most proof of consistent and predictable efficacy than any other device on the market. Hairmax® leads and never follows, from FDA Clearances to Clinical Studies to the variety of laser device models available, we are the world wide leaders in home use laser hair technology.
HairMax: The Pioneers of At- Home Low Level Laser Hair Loss Treatments
Hairmax® pioneered at home laser phototherapy treatment for hereditary hair loss. Hairmax® Laser devices have revolutionized the way men and women around the world treat their hair loss. Prior to Hairmax®, treatment options were limited to oral and topical drugs. There were only two drugs, Propecia®/finasteride and Rogaine® 5%/minoxidil approved for treating hair loss in males, and only one drug, Rogaine® 2%/minoxidil available to women.
With Hairmax® laser devices a safe and effective, non-drug, non-topical treatment option is available. In fact, a peer review medical journal article published by leading authorities in the field of hair loss compared the clinical results of Hairmax® Laser treatments with clinical results of minoxidil and Propecia and found them to be comparable. Of utmost importance, HairMax® Laser devices have an excellent safety record, with no harmful side effects ever reported.
HairMax® Hair Loss Treatment FDA Clearance*
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.
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)*. To date, close to a million people around the world have chosen to use the Hairmax® Laser devices to treat their hair loss and enrich their lives.
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.