HairMax LaserComb - Information for Healthcare Professionals

FDA Clearance

Summary:

Proven efficacy key part of 510(k) submission - 5 FDA Clearances received to date
FDA Clearance for marketing received in 2011 for females with AGA
FDA Clearance for marketing received in 2007 for males with AGA
Indicated for the treatment of AGA and promotion of hair growth*
The HairMax can be used as monotherapy, combination or adjunctive therapy
Results of clinical study published in peer review journal

In June 2011, the FDA granted marketing clearance for the promotion of hair growth in females with androgenetic alopecia*. In August 2011, the FDA granted marketing clearance for the new HairMax Dual 12 model.

In May, 2011, the FDA granted marketing clearance for 3 new HairMax models for the treatment of AGA in male*.

In January 2007, the HairMax® LaserComb became the first ever medical laser device to receive FDA marketing clearance for the promotion of hair growth in males with androgenetic alopecia*.

The HairMax LaserComb device is the only home use laser phototherapy to receive the FDA imprimatur for males and females. The device can be used either alone or as an adjunct to other treatments.

Note: HairMax LaserComb's FDA 501(k) Clearances as a medical devices for marketing was based on proof of EFFICACY & SAFETY. Read More

Why FDA Efficacy Trials?

Lexington has conducted 7 clinical trials with 460 subjects to date. Also, no serious side effects have ever been reported in any clinical studies. Hand-in-hand with Lexington International’s unwavering commitment to provide an effective non-drug treatment for androgenetic alopecia, 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.

For this reason, we have vigorously pursued FDA marketing clearance. With these milestone accomplishments, we can now assure you and your patients of our devices' effectiveness and safety.

The results of the key clinical study performed with the HairMax LaserComb in 2006 which led to FDA Clearance to market in 2007 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 clearances. With these milestone accomplishment, we can now assure you and your patients of our devices' effectiveness and safety.