Ellman International Inc, of Oceanside, NY, has announced Food and Drug Administration clearance of its Pelleve, a skin tightening system for the non-ablative treatment of mild to moderate facial wrinkles and rhytids for skin phototypes I-IV.
According to the company, FDA approval was given after it submitted clinical data, showing that a single treatment with the high frequency radiowave device can safely and effectively tighten and improve the appearance of skin through six months.
Specifically, Pelleve employs advanced radiowave technology of the Ellman International Surgitron Dual RF S5 and a proprietary Pelleve handpiece to precisely deliver energy through the skin to the dermal tissue beneath without damaging the epidermis. Collagen denaturization and contraction is achieved through gentle heating of the deeper dermal tissue. New collagen synthesis takes place as the dermal tissue recovers.
For the clinical trial, 83 women and 10 men were given a single treatment with the Pelleve handpiece. Performed in an ambulatory (outpatient) setting, the treatment did not require any need for skin cooling products or anesthesia. Depending on size of the area, it took an average of 15 to 20 minutes. According to Ellman, more than 87% of patients demonstrated measurable and immediate positive results in a blinded assessment of skin laxity and wrinkle improvement with continued response at six months after treatment.
[Source: Original press release]