HairMax LaserComb FDA Clearance: A Milestone in Hair Care, Hair Growth and Hair Science

In January 2007, the HairMax LaserComb® became the first and only medical laser device to receive FDA Clearance to market for the "Promotion of Hair Growth" in males.

HairMax LaserComb's FDA 501(k) Clearance as a medical device for marketing was based primarily on proof of EFFICACY.

The HairMax LaserComb is also a non-topical, drug free treatment option – something that makes the HairMax highly distinct from the other clinically proven products.

HairMax Studies and the FDA Clearance Process

After years of extensive research and randomized clinical studies, Lexington International submitted the results of its six-month, multi-center placebo controlled clinical trials in 2006. The data collected from the trials indicated that 93% of the participants, all males aged 30-60, had a medically significant increase in hair growth, and evidence that 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 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 official indication is for "the Promotion of Hair Growth in males with Androgenetic Alopecia who have Norwood Hamilton Classifications of IIa-V and Fitzpatrick Skin Types I to IV." (The clinical trial to assess the efficacy of the HairMax LaserComb laser hair growth treatment in females was just completed and will be reported on at a later date.)

Study Significance

Hand-in-hand with Lexington International’s unwavering commitment to customer satisfaction, the makers of the product pursued these costly clinical trials to help put our customers’ minds at ease while solidifying the effectiveness of the HairMax.

To put it simply, we know about the countless products on the market that promise to re-grow hair, but end up having little or no effectiveness. And apart from draining your pocket, they do nothing to improve your hair loss problem.

The clearance of the HairMax LaserComb for marketing means that all data submitted was subject to intense scrutiny and review before being cleared for marketing.  When a company receives this clearance, there are stringent rules and high standards put into place covering all aspects of manufacturing and quality control.  The HairMax LaserComb is the only Laser PhotoTherapy device that was reviewed by the FDA and cleared for marketing. Our clinical data was submitted to the FDA and rigorously reviewed.

It is this milestone clearance that allows us to ensure the effectiveness of the HairMax.

A Truly Unique Alternative

The FDA marketing clearance of the HairMax LaserComb® has significant implications for the Hair Loss Treatment industry. Currently, there are only two other approved treatment modalities available, but with the addition of the HairMax, there is now a viable alternative to these methods. With the HairMax, no longer do you need to worry about ongoing expenses or deal with negative side effects.

Note that while the HairMax works well as a standalone treatment, it is possible to use it in conjunction with the other approved therapies of your choosing. Remember, fighting hair loss is an uphill battle and the FDA clearance to market of the HairMax* now makes you one step closer to winning your battle with hair loss.

Customer Satisfaction is of Primary Importance   Clinically Proven to Promote Hair Growth* Greater than 90% User Satisfaction Reported Patented and Manufactured in the USA ISO Quality Assured

* The HairMax Advanced 7, Lux9, 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 Fitzpatrick Skin Types I to IV.

The HairMax Lux 9 model is indicated to treat Androgenetic Alopecia, and promote hair growth in females who have Ludwig (Savin) I-4, II-1, II-2, or frontal patterns of hair loss and Fitzpatrick Skin Types I to IV.