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LEXINGTON INTERNATIONAL,
LLC
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Press Release
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HairMax LaserComb Certified for European
Safety Standards with CE Marking

Boca Raton, Florida, Sept. 8, 2003
– The HairMax LaserComb, the first hand-held Laser PhotoTherapy device
for thicker, fuller, healthier hair, has received CE certification for
conformity with the essential health and safety requirements set out in
European Directives.
According to CEO David Michaels
of Lexington International, manufacturer of the LaserComb, “CE certification is
much like a passport for product sales to the 18 nations that make up the
European Economic Area (EEA). With HairMax’s advanced treatment for thinning
hair, it is important to show that the LaserComb meets the safety and health
requirements established by the European Member States.”
“In order to facilitate increased
sales to EU member nations, we have added Euro monetary transactions to the
on-line ordering at our www.hairmax.com secure website,” said Randy Veliky,
Chief Operations Officer at Lexington International.
The HairMax LaserComb is a unique
laser light therapy device that is currently undergoing FDA review for
clearance as a medical device for hair loss. The LaserComb has been certified
in Canada
as a Class 2 Medical Device cleared to stop hair loss and regrow scalp hair in
men and women.
The CE marking
refers to the safety of a product and
CE certification is another major clearance by the LaserComb as being safe for
use by consumers. The LaserComb also meets FDA requirements for laser safety.
The CE marking indicates conformity with mandatory
European safety requirements. European conformity is certified by following
clear and understandable ‘conformity assessment procedures’. Lexington
International is represented for regulatory affairs in
Europe by
Emergo Europe, headquartered in
The Hague
in the Netherlands.
“We often hear the
question, ‘Is the LaserComb safe?’ said David Michaels. “We hope this goes a
long way toward definitely answering that question.” The LaserComb was
developed from nearly two decades of clinical research and is manufactured and
patented in the USA with patents pending in over one hundred countries around
the world.
For information:
http://www.hairmax.com or
Contact:
mediarelations@hairmax.com
Phone: 1-800-410-HAIR

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