Pelleve Receives FDA Clearance for Treating Facial Wrinkles
Posted May 18 2009 10:44pm
One more new product for wrinkles, a gel is applied before the device is used and it creates a warming effect. The process can be used before a Botox treatment and tightens the skins. It is a non invasive procedure that promises results right away. The process has been used in Europe since 2005. BD
OCEANSIDE, N.Y., May 18 /PRNewswire/ -- Ellman International, Inc. announced today that the Food and Drug Administration (FDA) has granted clearance to Pelleve(TM), a skin tightening system for the non-ablative treatment of mild to moderate facial wrinkles and rhytids for skin phototypes I-IV. The clearance was granted based on clinical data demonstrating that a single treatment with the high frequency radiowave device can safely and effectively tighten and improve the appearance of skin on the face through six months.
"Today's FDA clearance of the Pelleve system represents a very exciting step in the introduction of next-generation high frequency radiowave technology to physicians and patients in the United States," said Rick Epstein, CEO of Ellman International, Inc. "Pelleve offers safe, non-invasive facial rejuvenation with no need for a local anesthetic and minimal discomfort -- a significant evolution from previous-generation technologies in this class."
Designed to work in conjunction with the Surgitron Dual RF S5 platform, Ellman's patented 4.0 MHz radiowave unit, Pelleve handpieces represent just one of hundreds of accessories available for office and clinic environments. The Surgitron Dual RF S5 provides maximum control in precision cutting and energy delivery, with more versatility than other energy-based technologies. "Ellman's proven product platform enables medical professionals to perform surgical procedures that produce less tissue damage and pain than the competition. Adding Pelleve offers tremendous value to physicians, as customers ask for the latest in cosmetic correction from their dermatologists, plastic surgeons and other healthcare professionals," said Epstein. Pelleve will be introduced to the U.S. market this month through dermatologists, plastic surgeons, ENTs and other cosmetic surgery clinics.