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News

2011

HAIRMAX LASERCOMB EXPANDS DISTRIBUTION TO NEIMAN MARCUS ONE OF THE NATION’S LEADING RETAILERS

Press Release (PDF) Lexington is pleased to announce that the HairMax LaserComb is now available at select Neiman Marcus select stores in Texas and Florida. The HairMax LaserComb will be the exclusive device for treating hair loss offered at Neiman Marcus stores. Boca Raton, FL (Dec 13, 2011) - Lexington International, manufacturer of the HairMax LaserComb®, the only home-use laser phototherapy device for hair growth in men and women to have FDA 510(k) Marketing Clearance, is pleased to announce that the HairMax LaserComb® is now offered for sale in select Neiman Marcus stores in Texas and Florida. Future plans call...

December 15, 2011
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FDA GRANTS CLEARANCE FOR THE HAIRMAX DUAL 12 MODEL FOR THE TREATMENT OF FEMALE PATTERN HAIR LOSS.

Press Release (PDF) Lexington International, LLC is pleased to announce that it has received FDA Marketing Clearance for the HairMax Dual 12 home-use laser phototherapy device for hereditary hair loss in females. Boca Raton, FL (August 24, 2011) - Boca Raton, FL - Lexington Int’l is proud to announce that the FDA has granted Marketing Clearance for their new model of a home-use laser phototherapy device, the HairMax Dual 12. Based in part on submission of clinical results which demonstrated efficacy and safety, the FDA Granted Class II Marketing Clearance 510(k) #K111714 indicated for the ‘Treatment of Hair Loss and...

November 24, 2011
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ANALYSIS OF RESULTS OF SAFETY AND EFFICACY OF THE HAIRMAX LASERCOMB FROM SIX CLINICAL STUDIES INDICATES EXCELLENT RISK TO BENEFIT PROFILE IN TREATING HEREDITARY HAIR LOSS.

Press Release (PDF) An analysis undertaken to assess the safety and efficacy of the HairMax LaserComb from 6 double blind clinical studies with 460 subjects found that no serious side effects occurred in any of these studies which proved the efficacy of the device in treating androgenetic alopecia (hereditary hair loss) in men and women. This analysis combined with the fact that there have never been any reports of serious side effects occurring in the over 10 years the HairMax has been on the market, demonstrates that the HairMax LaserComb has an excellent risk to benefit profile. Boca Raton,FL (November...

November 03, 2011
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NEW FDA CLEARANCE FOR THE HAIRMAX LASERCOMB FILLS AN UNMET NEED OF PROVIDING AN EFFECTIVE, NON-DRUG HOME-USE DEVICE FOR TREATING HAIR LOSS.

Press Release (PDF) Boca Raton, FL. (Oct 19, 2011) - Lexington International, LLC, is pleased to announce that the company has received FDA 510(k) #K112524 Marketing Clearance for two new models of the HairMax LaserComb®, laser phototherapy medical device for the treatment of hereditary hair loss in women. FDA Clearance Letter Link:http://hairmax.com/mediakit/docs/FDA_Clearance_adv7_pro12.pdf Hereditary hair loss is a devastating condition affecting over 30 million women in the United States. Until recently, when the HairMax Lux 9 was initially FDA Cleared for marketing for treatment of females, there had been only one FDA approved drug for treating this condition in women. This...

October 17, 2011
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HAIRMAX LASERCOMB EXPANDS INTERNATIONAL PRESENCE WITH APPROVAL BY THE EGYPTIAN MINISTRY OF HEALTH.

Press Release (PDF) Lexington Int’l announces approval by the Egyptian Ministry of Health for the three models of the HairMax LaserComb® as a home-use laser phototherapy device to promote hair growth and treat hair loss. Boca Raton,FL (Oct 05, 2011) - Lexington International, LLC, developer and manufacturer of the HairMax LaserComb is pleased to announce that the HairMax LaserComb has been approved by the Egyptian Ministry of Health to market the three models of the device in that country, the HairMax Advanced 7, the Lux 9, and the Professional 12. With this approval, Egyptians now have a new and effective...

October 05, 2011
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