- Proven efficacy key part of 510(k) submission
- 6 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 official indication for the HairMax LaserComb is:
The HairMax Advanced 7, Lux 9, and the Professional 12 models are indicated to treat Androgenetic Alopecia, and promote hair growth in males who have Norwood Hamilton Classifications of IIa to V and in females who have Ludwig (Savin) I-4, II-1, II-2, or frontal patterns of hair loss and who both have Fitzpatrick Skin Types I to IV
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 and females 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.
All of the clinical trials provided conclusive evidence that the HairMax is effective and safe for the treatment of pattern hair loss in both men and women* and were a key factor in FDA 510(k) Clearances. The HairMax is a viable treatment option for those wishing to avoid the use of drugs and/or topicals.
The results of the key clinical study performed with the HairMax LaserComb which led to the original 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. The studies also showed that there were no serious adverse effects in any of the trial participants.
THE SCIENCE OF HAIR GROWTH