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- Laser Therapy
The HairMax Laser Comb is a compact version of large laser therapy machines that have been used by hair clinics around the world to stimulate hair to increase in thickness and thus appear fuller. The unique aspect of the product is that the comb’s teeth parts the hair and allows the laser light to more easily reach the scalp in areas of existing hair. The instrument emits a beep every four seconds to tell the user to advance the device to a new part of the scalp.
The HairMax LaserComb is manufactured by Lexington International, LLC in Boca Raton, Florida. According to the manufacturer, the Laser Comb works by dilating blood vessels and increasing the blood supply to hair follicles.
The wavelength of the HairMax LaserComb is in the red spectrum, probably around 660nm. The power output for this instrument appears to be somewhere between 30 and 500 milliwatts. Exact product specifications have not been disclosed. As a reference, the visible light spectrum is between 380nm (violet) and 750nm (red). The specific red spectrum ranges from 625nm to 750nm.
The FDA clearance through 510(k) notification was based on a clinical study in four sites in the United States. Results showed that 93% of the participants (ages 30-60) had an increase in the number of terminal (thick) hairs. In the treatment group, the average number of terminal hairs per square centimeter increased by 19 hairs/cm² over a six-month period. For the same period, the number of hairs in the control group decreased by 10.6 hairs/cm2, so the actual increase was 29.4/cm2. The base hair counts in both groups were 125 hairs/cm2. As a reference, the average non-balding person has approximately 220 hairs/cm2.)
To obtain 510(k) clearance, the company was required to submit both safety and efficacy data to the FDA. It is important to note that standards for 510(k) clearance for medical devices is not as rigorous as the large-scale, multi-center studies required for PMA (pre-market authorization) for drugs.
During the study, there were no reports of serious adverse reactions. A major limitation of this study is that the treatment period was only six months so that the long-term results and safety are unknown.
The FDA Cleared HairMax to treat female pattern hair loss on June 6, 2011. The specific device, manufactured by Lexington Intl, LLC, is called the HairMax LaserComb Lux 9. It is cleared to treat female hair loss and promote hair growth. Included as a key part of the submission was a multi-center clinical study proving the efficacy and safety of the medical device in women.
The Hair Max Laser Comb can be purchased at our office for $500 plus tax. It is also available online at www.hairmax.com.
- Lexington International, LLC LaserComb 510(k), January 18, 2007.
- Satino JL, Markou M. Hair regrowth and increased hair tensile strength using the HairMax LeserComb for Low-level laser therapy. Int J Cosm Surg and Aesthetic Derm, 2003; 5(2):113-117.
- Sommer AP, et al. Biostimulatory windows in low-intensity laser activation: lasers, scanners and NASA’s light-emitting diode array system. J Clin Med and Surg, 2001; 19(1); 29-33.