FDA Approves HairMax LaserComb to Treat Baldness
WASHINGTON Feb 15, 2007 (AP)— Drawing this special comb over a balding pate could restore some real hair according to a Florida company. The Food and Drug Administration has cleared for sale a handheld laser device to promote hair growth.
Called the Hairmax Lasercomb, it increases the numbers of thick hairs on the scalp, according to 26-week clinical trials conducted by its manufacturer, Lexington International LLC.
As the device's name suggests, it combines a low-level laser with a comb. When drawn through the hair, the laser strikes the scalp to promote hair growth, according to the company.
The device, sold on the Web for US$545, is the only drug-free product meant for home use in combatting hair loss that's won the endorsement of the FDA, the company said.
News Release
FDA CLEARS THE HAIRMAX LASERCOMB FOR THE PROMOTION OF HAIR GROWTH
February 2007 – Lexington International LLC is proud to announce the landmark achievement of US Food & Drug Administration (FDA) clearance for their medical laser device, the HairMax LaserComb®. Through years of extensive research and clinical studies in the science of hair growth, Lexington has developed an affordable and convenient, hand-held laser device, now clinically proven to promote hair growth in males with androgenetic alopecia (Norwood IIA to V with Fitzpatrick skin types I to IV).
To view FDA’s public record of this clearance visit www.fda.gov/cdrh/pdf6/K060305.pdf.
This FDA clearance of the HairMax LaserComb offers an exciting new modality for the promotion of hair growth in males. 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. But the HairMax LaserComb stands out as the only proven drug-free alternative. This gives many hair loss sufferers, previously unable or unwilling to turn to drug-based solutions, newfound hope in their battle. 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.
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.
Lexington’s clinical study investigating the efficacy of the HairMax LaserComb in females is concluding and they will be submitting the data to the FDA shortly.
