Summary:
- Proven efficacy key part of 510(k) submission
- FDA Clearance for marketing received 2007
- Indicated for promotion of hair growth*
- The HairMax can be used as monotherapy, combination or adjunctive therapy
- Results of clinical study published in peer review journal
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In January 2007, the HairMax® LaserComb became the first ever medical laser device to receive FDA marketing clearance for the following indications and uses:
"Promote hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Skin Types I to IV."
The HairMax LaserComb device is the third product to receive the FDA imprimateur. The device can be used either alone or as an adjunct to other treatments.
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Why FDA Efficacy Trials?
Hand-in-hand with Lexington International’s unwavering commitment to customer satisfaction, was the pursuit of this costly clinical efficacy trial to help quantify the effectiveness of the HairMax LaserComb and to prove that it truly works to promote hair growth in males with Androgenetic Alopecia.
The results of the key clinical study performed with the HairMax LaserComb which led to FDA Clearance to market was published in the May 2009 Issue of Clinical Drug Investigation. 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.
For detailed results of this study, Please Click Here
To put it simply, we know about the countless devices on the market that promise to re-grow hair, but end up having little or no effectiveness.
For this reason, we vigorously pursued FDA marketing clearance. With this milestone accomplishment, we can now assure you and your patients of our devices' effectiveness.
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