Home-based laser hair-removal device gains first FDA clearance

February 8, 2008, Pleasanton, CA--SpectraGenics has obtained over-the-counter clearance from the United States Food and Drug Administration (FDA) for the first hand-held diode-laser hair-removal device designed for at-home use.

February 8, 2008, Pleasanton, CA--SpectraGenics has obtained over-the-counter clearance from the United States Food and Drug Administration (FDA) for its patented hand-held laser hair removal device designed for at-home use. The TRIA is the first hair removal laser to enter the U.S. home-based device market, an industry projected to grow exponentially over the next three years.

"The FDA clearance is the culmination of many years of research, clinical testing and innovative product design efforts," said Robert Grove, CEO, SpectraGenics. "Our engineers are the same scientists who developed the first and gold-standard professional diode laser hair removal system over 10 years ago, which is still used by physicians nationwide. We have invested significant resources to harness that same light-based technology to deliver a safe, effective way for consumers to treat unwanted hair in the privacy of their homes."

The TRIA device is the first at-home device to feature a diode laser specially designed to be safe and effective for at-home use. SpectraGenics has been selling a version of the TRIA, called i-Epi, in Japan since 2005. The TRIA is the first in a series of at-home science-based beauty devices to be pioneered by SpectraGenics.

"I have been performing laser hair removal in my office for 12 years and welcome the arrival of TRIA as an adjunct to professional laser hair removal," said Eric Bernstein, MD, Clinical Associate Professor at the University of Pennsylvania. "TRIA is simple, safe and very effective. Many of my patients will be able to use TRIA for touch-ups in between visits as well as on other areas not treated in-office to achieve and maintain beautiful results, and I expect it to increase the number of patients I see for laser hair removal. The TRIA was developed by the engineers who created the diode hair removal laser I use in my office today."

Professional laser hair removal is consistently the leading non-surgical cosmetic treatment for women 34 years and under, and the second most popular procedure for women over 35, according to the American Society for Aesthetic Plastic Surgery. The at-home device market is relatively new and expected to grow exponentially with the introduction of products targeted for treatment of hair, acne, wrinkles and skin rejuvenation.

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