Ellman International receives FDA 510(k) clearance for skin-tightening system

  • February 28, 2014

Ellman International announced it has received FDA 510(k) clearance to market its radiofrequency-based treatment system for tissue heating and temporary reduction in the appearance of cellulite.

The PelleFirm RF Body Treatment System has two large diameter handpieces that elevate tissue temperature up to 45 degrees Celsius and mechanical massage heads for treating cellulite, and is based off Ellman’s Pellevé radiofrequency-based skin tightening technology, according to a press release.

“[PelleFirm] addresses the need for an effective, non-invasive body solution,” Frank D’Amelio, president and chief executive officer, Ellman, said in the release. “PelleFirm can address almost every area of the body … [and] delivers visible results with no pain or downtime.”

“Many of my patients request treatment for sagging skin in their arms, hands, abdomen, thighs and gluteal area,” Josephine Hernandez, MD, a dermatologist and investigator for PelleFirm, said in the release. “I have seen PelleFirm results in as little as a few treatments.”

Ellman plans to formally launch PelleFirm March 21 at the American Academy of Dermatology meeting in Denver.

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