|
LaserComb Approved by Korean FDA
for the treatment of hair loss & thinning hair
*press release, reprinted with permission
from Hairmax
Korean FDA Approval of the HairMax LaserComb®
Expands Lexington International, LLC's International Portfolio of Approved
Medical Devices
Lexington International, LLC, manufacturer and distributor of the HairMax
LaserComb®, has obtained Korean FDA approval.
Boca Raton, FL (PRWEB) -- 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® (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.
Contact
Lexington International, LLC
Attention: Media Relations
561-417-0200
mediarelations@hairmax.com
|
 |
