BOCA RATON, FL– The HairMax LaserComb, A Low Level Laser Device for hair received certification by the Canadian Government as a Class 2 Medical Device. Medical claims can now be made in Canada.
The HairMax LaserComb, manufactured by Lexington International LLC, is a personal device for delivering Low Level Laser Therapy (LLLT) to hair. According to Lexington International, LLLT uses the stimulating effects of laser light in the natural, scientific process known as PhotoBioStimulation to also improve the quality and thickness of hair.
Based on appropriate scientific information and clinical data submitted to Health Canada, and after examination of all data submitted, Medical Device License Number 61237 was granted to Lexington International allowing the following therapeutic claims to be made to the Canadian public.
- The HairMax LaserComb increases the strength of scalp hair in men and women.
- The HairMax LaserComb prevents scalp hairloss in men and women.
- The HairMax LaserComb causes regrowth of scalp hair in men and women.
“This is significant news and a medical milestone as the HairMax LaserComb is the first ever medical device for home use approved by any government to combat hairloss, especially for both men and women”, according to David Michaels, Managing Director of Lexington International LLC.
The HairMax LaserComb has been undergoing Clinical Trials throughout 2002. Clinical data will also be presented to the US FDA in mid 2003 for similar medical claims to be made to the American public. Currently, the HairMax LaserComb is classified as a Cosmetic Device in the USA that promotes thicker, fuller, healthier hair.
“Low Level Laser Therapy (LLLT) has been used internationally since the 1960s mostly for wound healing and pain relief”, states Dr. Martin Unger, MD, a world authority in hair restoration and Medical Director for Lexington International, “LLLT is now starting to become recognized in North America as an effective modality for Alopecia (Hairloss) and other dermatological medical conditions.” Dr. Unger adds “The HairMax LaserComb is also the first therapy to have shown an increase in hair strength with clinical data indicating an average increase of 79% in tensile strength.”
The LaserComb complies with FDA regulations for laser safety and is patented in the USA with patents pending in 104 countries around the world.