Cynosure Receives FDA 510(k) Clearance forCellulaze Cellulite Laser Workstation
First Minimally Invasive Aesthetic Device for Cellulite Reduction
Westford, Mass., January 30, 2012
Cynosure, Inc. (NASDAQ: CYNO) today announced that theU.S. Food and Drug Administration has cleared the
Workstation forcommercial distribution, giving millions of American women the first minimally invasive solution intheir battle against cellulite.
world’s first and only minimally invasive medical device de
signed to treat womenwho have struggled to eliminate cellulite through diet and exercise, or have tried the myriad of lotions
and creams currently on the market,” said Cynosure President and Chief Executive OfficerMichael Davin. “Unlike those products, C
ellulaze is the only aesthetic device that directly treats the
physiological structure of cellulite, providing clinically proven, results.”
An estimated 85% of women over the age of 20
have some form of cellulite
pockets of fat deposited just beneath the surface of the skin, around the hips, thighs, and buttocks, which
produces an “orange
peel” or a “cottage cheese” appearance.
In the United States alone, thetreatment of cellulite is a multibillion-dollar industry, according to market estimates.Cellulaze reduces cellulite
in just one treatment
by restoring the normal structure of the skinand underlying connective tissue.
Cellulaze diminishes the lumpy pockets of fat, releases the areasof skin depression typifying cellulite and increases the elasticity and thickness of the skin.Nearly four years of clinical research puts Cellulaze in a class of its own: the only single-treatment aesthetic procedure clinically shown to reduce cellulite. Clinical data has demonstrated that Cellulaze treatments can increase the thickness of the skin by 25% and increase the elasticity of theskin by 29% at one year. No other anti-cellulite treatment has been proven to deliver these results.
Harvard Women's Health Watch Cellulite meltdown. Harv. Health Pub. Group 5, 7 (1998).
Sainio, E.L., Rantanen, T. and Kanerva, L. Ingredients and safety of cellulite creams. Eur. J. Dermatol. 10, 596
Drealos, Z.D. and Marenus, K.D. Cellulite: etiology and purported treatment. Dermatol. Surg. 23, 1177