Ellman International, Inc., received FDA clearance to market its new PelleFirm RF Body Treatment System. The PelleFirm System is CE Marked for body skin tightening and cellulite reduction. In addition, it also has received FDA 510(K) clearance for tissue heating and the temporary reduction in the appearance of cellulite.
Ellman has received advance orders from international distributors and will formally launch the PelleFirm System to the US and international markets at the upcoming Annual Meeting of the American Academy of Dermatology (AAD), beginning March 21, 2014 in Denver, CO.
The PelleFirm System provides a non-invasive, pain-free RF treatment for the body, resulting in firmer skin and the impermanent reduction in the appearance of cellulite, according to Ellman. The company leveraged its expertise in RF based skin tightening with Pelleve in the development of PelleFirm. The system is comprised of two new, large diameter handpieces sized for the body that elevate tissue temperature up to 45 degrees Celsius, coupled with mechanical massage heads for treatment of areas with cellulite. PelleFirm is ideal for problem zones including the abdomen, arms, buttocks, and thighs.
The PelleFirm handpieces are powered by the Pelleve S5 RF Generator, which also powers the Pelleve Wrinkle Reduction handpieces for facial skin tightening. These new PelleFirm RF Body treatment devices are compatible with the recently released enhanced Pelleve S5 Generator, as well as the large worldwide installed base of the original Pelleve S5 Generators from Ellman.
"We have been working with physicians around the world to develop PelleFirm and are excited to bring this innovative RF Body treatment system to market. It addresses the need for an effective, non-invasive body solution," commented Frank D'Amelio, President & CEO. "With two different size handpieces, PelleFirm can address almost every area of the body. Like Pelleve, a PelleFirm RF Body Treatment system delivers visible results with no pain and no downtime."
Josephine Hernandez, MD, a dermatologist and a primary PelleFirm clinical investigator, said, "Many of my patients request treatment for sagging skin in their arms, hands, abdomen, thighs and gluteal area." She commented further, "The results (with the PelleFirm system) are outstanding and superior to any of the many body contouring or skin tightening devices we have used in our practice. I have seen PelleFirm results in as little as a few treatments. We are very satisfied users."Next Story