The protocol for the study was approved by an IRB (Investigational Review Board) and monitored by a CRO (Contract Research Organization). The trials were listed on www.clinicaltrials.gov  which is a registry of federally and privately supported clinical trials conducted in the United States and around the world. Mr. David Michaels, Managing Director of Lexington said, "Female hair disorders, especially hair loss, negatively impact the lives of millions of women. User satisfaction with other treatments has been relatively low. A highly effective user-friendly product for hair growth remained an unmet need for women. With this FDA Clearance for the treatment of females, the HairMax will now offer effective relief to enrich the lives of both men and women with hereditary hair loss."   

How Does the HairMax Work? How does the HairMax LaserComb work so effectively? It harnesses the power and technology of laser light. The HairMax delivers safe and effective laser energy to stimulate dormant and active hair follicles. Lexington research supports the theory that low level laser energy is able to stimulate the prodution of ATP by releasing bound nitric oxide in the cellular respiratory chain which increases metabolic energy, promotes microcirculation, contributes to regulation of cellular apoptosis, and stimulates cell proliferation. Clinical evidence demonstrates reverse miniaturization, increase in number of hairs per follicular unit, and induction and prolongation of the anagen phase.  

Safe to Use: The HairMax Lux 9 complies with FDA requirements for laser safety. There has never been any reports of serious side effects occurring either in clinical trials or in the 10 years the device has been on the market. The HairMax uses a patented technology to part the hair allowing the focused laser energy to reach the scalp. The laser is most effective when it has an unobstructed path directly to the hair follicle. Through extensive research, Lexington has determined the optimal wavelength and energy level needed to deliver maximum results. Lexington's continued dedication to innovation ensures that users are always receiving the latest in laser hair technology.

Randy Veliky, Lexington COO said. "The HairMax Lux 9 FDA Clearance now expands the options for the treatment of both male and female pattern hair loss. For the first time, the combination of our patented technology, state of the art design and the proven efficacy will help relieve the suffering of the millions of men and women with hair loss."

In April 2011, the FDA also granted Clearance for marketing for 3 new models of the HairMax LaserComb for male pattern baldness.

Since 2001, Lexington has completed a total of seven clinical studies with 460 subjects. All of the studies have demonstrated the efficacy and safety of the HairMax LaserComb family of FDA Cleared devices. These statistically significant clinical study results validate the fact that the HairMax should be considered as a first line treatment for appropriate people suffering from hereditary hair loss.

 About Lexington International, LLC Based in Boca Raton, Lexington is a manufacturer and developer of advanced phototherapy devices for home use. Lexington International markets the only laser device that has published the results of the efficacy of the device in a peer review journal. The HairMax is also the first and only device of its kind with FDA Clearance for marketing. Over the past 10 years and in over 155 countries worldwide, Lexington has helped hundreds of thousands of individuals to treat their hair condition. For more information about the HairMax Laser Combs, please contact Freedom Hair Systems.  If you are ready to start treating your hair, please visit www.TheFreedomStore.ca for all of your HairMax needs.