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Cellulaze_510(k)_1_30_2012

Cellulaze_510(k)_1_30_2012

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Published by Alan J Bauman MD
FDA approved for cellulite. Minimally-invasive cellulite reduction. Cottage-cheese BEGONE!
FDA approved for cellulite. Minimally-invasive cellulite reduction. Cottage-cheese BEGONE!

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Published by: Alan J Bauman MD on Feb 03, 2012
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02/11/2014

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Contact:Investors Media
Scott Solomon Behrman CommunicationsSharon Merrill Associates, Inc. 212.986.7000617.542.5300CYNO@InvestorRelations.com 
Cynosure Receives FDA 510(k) Clearance forCellulaze Cellulite Laser Workstation
World’s
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
Company’s Cellulaze™
Workstation forcommercial distribution, giving millions of American women the first minimally invasive solution intheir battle against cellulite.
“Cellulaze is
the
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
1,2
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.
3
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.
1
Harvard Women's Health Watch Cellulite meltdown. Harv. Health Pub. Group 5, 7 (1998).
2
Sainio, E.L., Rantanen, T. and Kanerva, L. Ingredients and safety of cellulite creams. Eur. J. Dermatol. 10, 596
 – 
 603 (2000).
3
Drealos, Z.D. and Marenus, K.D. Cellulite: etiology and purported treatment. Dermatol. Surg. 23, 1177
 – 
1181(1997).
 
2
“Based on the scientific data and the patient results we have obs
erved over the past several years of evaluating the device, Cellulaze represents a new and highly effective standard of treatment for
cellulite,” said
Barry E. DiBernardo, MD, a board certified plastic surgeon and Clinical AssociateProfessor, Department of Surgery, Division of Plastic Surgery, University of Medicine and Dentistryof New Jersey. Dr. DiBernardo, one of five clinical investigators in a multi-center study of Cellulaze,has published one year results on a subset of the treated patients.
4
 
“The
study was designed with both traditional, subjective measurements of clinical improvement and new objective, quantitative measures as well. All of the analysis led to the conclusion that patients treated with Cellulaze maintained results at least one yea
r,” said Dr. DiBernardo.
 Cellulaze uses a proprietary SideLight 3D
side-firing technology to target the causes of cellulitebeneath the skin: herniated pockets of fat, stiffened septae and thin skin. During the procedure, atiny laser fiber is inserted under the skin, which gently heats the skin and disrupts or melts the fat.Next the laser releases the fibrous bands that create the dimpling effect from pulling down on theskin. This release creates a smoother look.
Finally the laser’s energy
stimulates collagen production
to increase skin’s
thickness and elasticity for a more even, healthier appearance.Patients usually see improvements within a few weeks, with the most significant results continuingto develop for a few months following the procedure. Cellulaze also complements other bodyshaping technologies, such as
Cynosure’s Smartlipo™
family of workstations.Cellulaze is also currently being marketed in Canada, the European Union, Australia and SouthKorea. Cynosure is pursuing regulatory approvals in additional international markets.
 About Cynosure, Inc.
Cynosure, Inc. develops and markets aesthetic treatment systems that are used by physicians andother practitioners to perform non-invasive and minimally invasive procedures to remove hair,treat vascular and pigmented lesions, rejuvenate the skin, liquefy and remove unwanted fat throughlaser lipolysis, reduce the appearance of cellulite and treat Onychomycosis. Cynosure's productsinclude a broad range of laser and other light-based energy sources, including Alexandrite, pulsedye, Q-switched, Nd:YAG and diode lasers, as well as intense pulsed light. Cynosure was founded in1991. For corporate or product information, contact Cynosure at 800-886-2966, or visit www.cynosure.com.
 
4
 
DiBernardo, BE, “Treatment of Cellulite with One Year Follow
-up using a
1440nm pulse laser”
 Aesthetic Surgery Journal
,March 2011

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