Ellman International, maker of the radiofrequency-based Pelleve facial skin-tightening system, has 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. The PelleFirm handpieces are powered by the Pelleve S5 RF Generator, which also powers the Pelleve Wrinkle Reduction handpieces for facial skin tightening.
"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,” said Frank D'Amelio, president & CEO of Ellman. "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."
The system will be introduced at the upcoming Annual Meeting of the American Academy of Dermatology (AAD), beginning March 21, 2014 in Denver, Colorado.
