Boca Raton, FL (PRWEB) October 22, 2008
Lexington International, LLC, manufacturer and distributor of the HairMax LaserComb®, the only clinically proven medical device alternative to stop thinning and regrow hair, has obtained Korean FDA approval. Lexington submitted clinical data from both male and female studies, along with ISO and GMP accreditations to achieve this approval.
The size of the Korean hair loss market cannot be understated. On July 31, 2008 a survey was published entitled World Hair Loss Survey Among Men. The survey results indicate the estimated Korean hair loss population to be 4.04 million (up 670,000 from the same survey result in 1999) with a men's hair loss ratio in South Korea of 22.41%. Additionally, the idea of hair loss is not as readily accepted among Koreans as compared to Western Society.
Furthermore, the Korean FDA Approval of the HairMax LaserComb® adds to an already large portfolio of medical device approvals and patents held by Lexington worldwide. Lexington International, LLC has invested substantial resources in conducting clinical studies to gain its international acceptance from governments, medical experts, and consumers.
Seung Hwan Chung, President Hanbul Pharm.Co.,Ltd., stated, "there is a social stigma associated with excessive hair loss, and in extreme cases the psychological affect can be severe. We feel that the HairMax LaserComb is a breakthrough product in the hair care industry. We are truly excited to have partnered with Lexington International to market the Hairmax Lasercomb in Korea."
Co-founder and Managing Director of Lexington International, LLC, David Michaels was elated by the approval and said, "once again, this approval qualifies Lexington's commitment to comply with all international standards to become the leading choice for all those experiencing hair loss". Further expressing his enthusiasm, Mr. Michaels commented, "we are excited about the Korean market and actively distributing qualified laser devices for hair and skin care".
Through Lexington's ongoing commitment to clinical research and development, the HairMax LaserComb® has achieved medical device clearance by the US FDA, Health Canada, Singapore Health Authority, Israeli Ministry of Health, Russian Federation of Health, and Brazilian ANVISA.
With the advent of approval by the Korean FDA for the HairMax LaserComb®, Koreans now have a new drug free modality to grow thicker, healthier, and fuller hair in the privacy and convenience of their home.
The HairMax LaserComb is the first and only FDA cleared hand-held laser device that utilizes low-level laser therapy to improve the appearance of hair at an affordable price. With no reported side effects, and an incomparable satisfaction rate, the LaserComb is revolutionizing the hair care industry.
For more information, please visit http://www.hairmax.com/
About Lexington International, LLC
Originating in Sydney Australia and now based in Boca Raton Florida, Lexington manufactures and distributes the HairMax LaserComb® (http://www.hairmax.com) to more than 89 countries and has provided new hope and satisfaction to tens of thousands of customers since 2001.
The HairMax LaserComb is the first and only FDA cleared hand-held laser device that utilizes low-level laser therapy to improve the appearance of hair at an affordable price. With no reported side effects, and an incomparable satisfaction rate, the LaserComb is revolutionizing the hair care industry. The HairMax LaserComb is based on 20 years of international research and studies on the effects of Low Level Laser use. Both the press and users alike have universally taken to the HairMax LaserComb. In January 2007, a regulatory milestone, HairMax was the first and only device Cleared by the FDA for the Promotion of Hair Growth.
Lexington is an ISO 9001 & 13485 Quality Assured laser manufacturer. Lexington is committed to GMP (Good Manufacturing Practices) of a medical device manufacturer. Clinical studies closely adhered to GCP (Good Clinical Practices) reviewed by an IRB (Ethics Committee). Lexington is also a member in good standing of the Better Business Bureau.
Lexington International, LLC
Attention: Media Relations
mediarelations @ hairmax.com