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Laser Comb- non-invasive home-use laser device
Laser Comb- non-invasive home-use laser device
This medical device uses low level laser to stimulate the scalp and energizes hair follicles, help to maintain your existing hair and retard shedding.
FOR IMMEDIATE RELEASE
(Free-Press-Release.com) July 17, 2011 --
The HairMax LaserComb® was designed and developed in Australia and is manufactured in the USA under strict quality control standards. Lexington International, LLC, based in Boca Raton Florida, manufactures and distributes the HairMax LaserComb. To date the HairMax LaserComb has been shipped to over 150 countries worldwide. Lexington International, LLC is a leader in hair growth, hair care and hair science.
According to their company official website, the Hairmax Lasercomb is the only FDA cleared laser phototherapy device for home use; they are the only company that has invested in and performed clinical research to prove efficacy of the home use phototherapy device and to submit them to the FDA in a formal 510(k) filing*.
Since 2001, there have been 7 clinical studies conducted with 460 subjects on the HairMax LaserComb®. In 2010, 2 of the studies were conducted on males and 2 were conducted in females.
These clinical results demonstrated that the Hair Max users would experience substantial decrease in hair fallout, faster hair growth; more manageability of hair and overall better quality and condition of hair. Moreover, no adverse side effects ever reported from treatment with the HairMax laser comb.
The HairMax Laser Comb is an easy to use and non-invasive home-use laser device; this medical device uses low level laser to stimulate the scalp and energizes hair follicles, help to maintain your existing hair and retard shedding.
*Key clinical studies
*In 2002 Dr. Michael Markou published the clinical study ‘International Journal of Cosmetic Surgery and Aesthetic Dermatology’ in the peer reviewed medical journal.
In 2005 key clinical study has been conducted supporting 510(k) Submission* to the FDA and subsequently gets clearance to market in 2007.
The article entitled, HairMax LaserComb Phototherapy Device in the Treatment of Male Androgenetic Alopecia, is indexed as Clin Drug Invest 2009: 29 (5): 283-292 in most of the biomedical databases such as MEDLINE, EMBASE/Excerpta Medica, etc. was published in the May 2009 Issue of Clinical Drug Investigation.
*510(K) SUBMISSION
The 510(k) Submission is the primary mechanism by which medical devices are accepted to the market in the USA. The FDA requires data to back equivalence claims, descriptive data and performance data to support this type of submission.
For more information, please log on to http://www.1lasercomb.com
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