The Medical Device Business Journal — Medical Device News & Articles | MassDevice
Syneron Medical Ltd. (NSDQ:ELOS) said it won a pair of regulatory nods for its VelaShape III "body shaping" device. GJ-F1
The Israeli cosmetic device maker said the device is designed to temporarily reduce waistlines and smooth cellulite. It uses infrared, bi-polar radiofrequency waves and vacuum to heat fat cells called adipocytes, prompting "localized reduction in skin laxity, volume and an overall improvement in skin structure and texture," according to Syneron’s website.
"In a VelaShape III clinical study of 42 patients, an average abdominal circumference reduction of 2.6 cm was recorded post-10 weeks following a single treatment," Dr. Ruthie Amir, global vice president of clinical affairs, said in prepare remarks. "Within the same study, we uncovered that 100% of the patients responded to the single treatment protocol with an abdominal circumference reduction of at a least 1.5 cm, with results seen as early as 2 weeks."
"We designed a sophisticated body shaping platform that delivers visible outcomes in a single or small number of treatments, fits the doctor’s business needs and leads the body shaping category to the next level. Together with our physician partners and engineers, our customers now have a clinically proven solution that addresses what consumers are telling us they want," CEO Shimon Eckhouse added.
Filed Under: Cosmetic/Aesthetic, News Well, Regulatory/Compliance Tagged With: CE Mark, Syneron Medical Ltd.
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