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To: Paul Kern who wrote (4176)	6/13/2005 12:15:06 PM
From: chowder	Respond to of 13449

12:12 [ELOS] Syneron's VelaSmooth gets FDA 510(k) OK for cellulite ---------------------------------------------------------- YOKNEAM, Israel, and TORONTO, June 13, 2005 /PRNewswire-FirstCall via COMTEX/ -- SyneronMedical Ltd. (Nasdaq: ELOS) today announces the US Food & Drug Administration(FDA) has granted 510(k) pre-marketing clearance to Syneron's VelaSmoothmedical device, powered by elos, for the temporary reduction in the appearanceof cellulite. The VelaSmooth also received clearance for the relief of minormuscle aches, pain and spasm and the temporary improvement of local bloodcirculation. The clearance of the VelaSmooth offers a new non-surgical, nodowntime alternative for patients wishing to treat the appearance ofcellulite. "The VelaSmooth incorporates a combination of technologies enabling deeperheating and mechanical manipulation of cellulite in a non-invasive manner,"said Dr. Tina Alster, director of the Washington Institute of DermatologicLaser Surgery and clinical professor of dermatology at Georgetown University."In our clinical study of 20 women of various ages and skin types withmoderate thigh and buttock cellulite, significant clinical improvement wasobserved in skin contour irregularities, and thigh circumferences were alsoreduced. Patients didn't lose weight, but they looked as if they had. Ourresearch has shown that it is no longer necessary to endure painful andlengthy recovery times or be exposed to general anesthesia that is typical ofother procedures like liposuction in order to achieve improvement ofcellulite."In addition to the 510(k) clearance, the FDA created a new product codefor the VelaSmooth, confirming its unique position in the aesthetic devicemarket. According to Dr. Amir Waldman, head of Clinical and Regulatory Affairsfor Syneron, "The FDA's designation of a new product category specifically forthe VelaSmooth reaffirms how technically innovative this device is for thetreatment of cellulite."Cellulite is a term used to describe the pitting, bulging and deformationof the skin usually affecting the thighs, buttocks, hips, breasts and theabdomen of women. More than 80 percent of women above the age of 18 havecellulite, regardless of their size, weight or physical fitness. Women aremore likely to have cellulite than men as men's fat cells reside deeper withinthe skin, while women's are closer to the surface, causing the ripplesassociated with cellulite."It is important for potential patients to understand that the VelaSmoothhas been cleared by the FDA as a medical device," said Domenic Serafino,president of Syneron Medical Inc. "Many companies offer lotions and devicesthat have claimed to have effectively treated cellulite. We are proud to bethe only company that has gone through the exercise of clinical studies withmore than 500 patients to verify the efficacy of the treatment."The VelaSmooth system, like all of Syneron's medical aesthetic devices, ispowered by elos(TM) (Electro-Optical Synergy). Elos, the first and onlycombined energy technology, uses Bi-Polar Radio Frequency (RF) and InfraredLight energy along with the added feature of negative pressure tissuemobilization. The synergy of the three components makes VelaSmooth aneffective treatment for those seeking a medical cellulite solution. Because itis a cleared medical device, the VelaSmooth is only sold to physicians for useby trained professionals under their medical direction.

To: Paul Kern who wrote (4176)	6/13/2005 12:15:29 PM
From: Paul Kern	Read Replies (1) \| Respond to of 13449

RE: ELOS FDA Clears Syneron VelaSmooth for Cellulite Treatment YOKNEAM, Israel, and TORONTO, June 13 /PRNewswire-FirstCall/ -- Syneron Medical Ltd. (Nasdaq: ELOS - News) today announces the US Food & Drug Administration (FDA) has granted 510(k) pre-marketing clearance to Syneron's VelaSmooth medical device, powered by elos, for the temporary reduction in the appearance of cellulite. The VelaSmooth also received clearance for the relief of minor muscle aches, pain and spasm and the temporary improvement of local blood circulation. The clearance of the VelaSmooth offers a new non-surgical, no downtime alternative for patients wishing to treat the appearance of cellulite. biz.yahoo.com