FDA Clearance

HairMax LaserComb® FDA Clearance for Males and Females:

A Milestone in the Treatment of Hair Loss and the Promotion of Hair Growth*

• HairMax FDA Cleared for marketing for females* in 2011
• 4 New HairMax models FDA Cleared for marketing in 2011
• HairMax was FDA Cleared for marketing in 2007 for males*
• Indicated for “Treatment of Hair Loss and Promotion of Hair Growth”*
• An ideal drug free treatment option
• All data submitted as part of 510(k) rigorously scrutinized and reviewed
• Clearance set up stringent requirements and standards in manufacturing and quality control
• HairMax can be used alone or with other medications

FDA Clearance Highlights

In June 2011, HairMax received FDA Clearance for hair growth in females with pattern hair loss*

In August 2011, HairMax Dual 12 model received FDA Clearance.

In April 2011, HairMax received FDA Clearance for three new models for the treatment of androgenetic alopecia (pattern hair loss)in males*.

In January 2007, the HairMax LaserComb® became the first and only medical laser device to receive FDA Clearance for marketing for the treatment of androgenetic alopecia (pattern baldness)in males.

Read FDA Clearance Press Release

HairMax LaserComb’s FDA 510(k) Clearance as a medical device for marketing was based primarily on proof of EFFICACY

Hand-in-hand with our commitment to customer satisfaction, we have pursued costly clinical trials to put our customers’ minds at ease while solidifying the effectiveness of the HairMax as a safe and effective hair loss treatment for both men and women.

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. Therefore, we embarked on an extensive clinical research program to prove the efficacy and safety of the HairMax LaserComb.

There have now been a total of 6 FDA Clearances of the HairMax LaserComb for marketing since 2007 which 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 has been reviewed by the FDA and cleared for marketing four times for the treatment of androgenetic alopecia (pattern hair loss) in both males and females*. Our clinical data was submitted to the FDA and rigorously reviewed for all 510(k) submissions.

It is these milestone clearances that allows us to ensure the effectiveness of the HairMax.

HairMax: A Truly Unique Non-Drug Hair Loss Treatment Option

The FDA marketing clearance of the HairMax LaserComb® has significant implications for the Hair Loss Treatment industry. Currently, there are only two other FDA approved hair loss treatments available, but with the addition of the HairMax, there is now a viable drug free, topical free alternative to these methods. The HairMax, has an excellent safety record, with no serious side effects. It is a one time purchase, with no ongoing costs.

Note that while the HairMax works well as a stand-alone 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.

HairMax Hair Loss Treatment Studies and the FDA Clearance Process

In 2010, Lexington Int’l submitted the results of its six-month, multi-center device controlled clinical trials for the treatment of female pattern hair loss to the FDA. The data from the trial indicated that 100% of participants, all 25-60, experienced hair growth. Further, subject assessment of thickness and fullness of hair was statistically significant for the HairMax over the control device. No serious side effects were reported.

In June 2011 the FDA granted marketing Clearance for the HairMax for the treatment of female pattern hair loss* based in part on the results of the 2010 clinical studies. In August 2011, the FDA granted marketing Clearance for the HairMax Dual 12 device and for 3 new HairMax models, the HairMax Professional 12, HairMax Lux 9 and HairMax Advanced 7.

After years of extensive research and randomized clinical studies, Lexington International submitted the results of its initial 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. No serious side effects were reported. Based on part of this study, the FDA granted initial marketing for the treatment of hair loss* in males.

All of the clinical trials conducted since 2006 have provided conclusive evidence that the HairMax is effective and safe for the treatment of male and female pattern hair loss*. 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.