FDA Clears the HairMax LaserComb® as the World's First At-Home Device to Promote Hair Growth

The HairMax Laser Comb has recently received FDA clearence to promote hair growth. Until now, the FDA has only approved two other products as solutions to combat hair loss, a condition that affects approximately 55 million men in the U.S. The HairMax Laser Comb® stands out as the only proven drug-free alternative. This affords many hair loss sufferers, previously unable or unwilling to turn to drug-based solutions, newfound hope in their battle against baldness.

New York, NY (PRWEB) February 22, 2007 -- Aside from a magic pill that can help people lost weight overnight, Boca Raton based Lexington International, LLC has the next best thing and it is the real deal: A hand held at home device to regrow hair for men and women with thinning pates. Skeptics cast your doubts aside: After years of stringent testing, data and research The FDA has cleared the HairMax LaserComb ® for the 'Promotion of Hair Growth' giving this product the distinction of being the world's first ever at home to device to make this incredible claim with regard to hair regrowth. To view the FDA's public record of this clearance visit www.fda.gov/cdrh/pdf6/K060305.pdf

Until now, the FDA has only approved two other products as solutions to combat hair loss, a condition that affects approximately 55 million men in the U.S. The HairMax Laser Comb® stands out as the only proven drug-free alternative. This affords many hair loss sufferers, previously unable or unwilling to turn to drug-based solutions, newfound hope in their battle against baldness.

For the FDA submission, Lexington conducted an extensive clinical study in four different locations across the United States. The study concluded that 93% of the participants (ages 30-60) using the HairMax LaserComb had an increase in the number of terminal (thick) hairs. The average number of terminal hairs per square centimeter increased by 19 hairs/cm² over a six-month period. During the study, there were no reports of serious adverse events. The number and types of adverse events were similar in both the active and placebo groups.

How does this invention work? Fortunately, treatments using the HairMax LaserComb are easy to administer, only 10 to 15 minutes three times per week, and the laser device is convenient to use in the comfort and privacy of your own home. HairMax has been precision-engineered into a compact device. Just pass it through your hair three times a week for about ten minutes for optimal results. Of course, everybody is unique and results differ among individuals, but anecdotal trials have shown that over 90% of users experience positive benefits and are satisfied with the results they achieve. In general, about 45% of users see noticeable improvements in as little as 8 weeks of treatment. Another 45% realize benefits from 8 to 16 weeks. A small group of users take longer, seeing results around 16 weeks.

100% Safe to Use: The LaserComb complies with FDA requirements for laser safety. The Laser affects only your hair and you achieve benefits without any worrying side effects. The HairMax LaserComb uses a patented technology to part the hair allowing the focused laser energy to reach the scalp. The laser is most effective when it has an unobstructed path directly to the hair follicle. Through extensive research, Lexington has determined the optimal wavelength and energy level needed to deliver maximum results. Lexington's continued dedication to consistent innovation ensures that users are always receiving the latest in laser hair technology.

COST:

The HairMax Laser Comb retails for $545.00 and is a good for life purchase sold on-line as well as to select physicians.

Dr. Matt Leavitt, Chief Medical Advisor to Lexington, states that, "The HairMax LaserComb is a method of treatment that can be of great help to men of all ages suffering from hair loss. I am impressed with the protocol and results from the clinical trials that Lexington has conducted. With the FDA clearing the HairMax LaserComb as a medical device, it offers an attractive option for hair growth for medical practitioners. We can now deliver a new modality to our patients and achieve strong user satisfaction."

To view before and after photos please visit: http://www.lasercomb.net/beforeafter.htm http://www.lasercomb.net/beforeafter.htm

**** We will gladly provide additional clinical data, JPEGS of the product, and product samples upon request. Dr. Matt Leavitt and HairMax founder David Michaels are available for interviews.

About Lexington International, LLC Originating in Sydney Australia and now based in Boca Raton Florida, Lexington manufactures and distributes the HairMax LaserComb® (www.hairmax.com) to more than 80 countries and has provided new hope and satisfaction to tens of thousands of customers since 2001. The HairMax LaserComb is based on 20 years of international research and studies on the effects of Low Level Laser use. Clinical studies closely adhered to GCP (Good Clinical Practices) with a protocols and case report forms reviewed by an IRB (Ethics Committee). Lexington is also a member in good standing of the Better Business Bureau. Additionally, the company was awarded by the U.S. Department of Commerce for "Commercial and Export Achievement".

###