HairMax Receives ANVISA Approval for Laser Devices for the Treatment of Hair Loss in Brazil
HairMax announces approval for HairMax® Laser devices by ANVISA in Brazil for home-use laser phototherapy devices to treat hair loss, thinning hair and the promotion of hair growth.
Sergio Borjas, Quality Systems and Regulatory Compliance Manager stated: "The approval process was arduous, taking 1 ½ years to complete and required an extensive submission of documentation including clinical study information, technical specifications and safety profile. This is a major achievement, as Brazil is a key market for HairMax."
As background, HairMax laser devices have been the subject of 7 clinical studies in 460 male and female participants. They have been conclusively proven both safe and effective in treating hereditary hair loss and promoting hair growth. In the clinical studies, over 90% of all subjects experienced hair growth with an average increase in hair count of 129 additional new hairs per sq. in. There are a range of devices available, which vary in the number of laser diodes and treatment time – from 15 minutes with the Prima model to as little as 90 seconds with the LaserBand 82 model. To date, over 1 million men and women around the world have treated their hair loss with HairMax devices.
David Michaels, Managing Director of Lexington said; "The introduction of HairMax in Brazil is a major milestone and continues our ongoing marketing efforts to expand distribution of HairMax laser devices in South America. Achieving the approval of ANVISA enables us to reach a wider audience of people suffering from hair loss in that vital region. 'Mr. Michaels stated, "Lexington will continue to pursue additional international medical device registrations to assure further availability of HairMax laser devices world-wide, to help hair loss sufferers regrow their hair and enrich their lives."
About Lexington International, LLC
Based in Boca Raton, Lexington Int'l is a pioneer in the development of advanced laser hair loss treatments and hair growth products. The HairMax Laser devices are the only laser phototherapy medical devices with 7 FDA Clearances for the treatment of hereditary hair loss in both men and women. Since 2001, in over 170 countries worldwide, Lexington Int'l., LLC has helped over half a million individuals treat their hair loss and improve the condition of their hair and enrich their lives.
For further information please visit: www.hairmax.com