Aesthetic device company Syneron Candela has received Food and Drug Administration (FDA) approval for the Profound handpiece.
The Profound, a minimally invasive, fractional radiofrequency microneedling device, has approval for the SubQ handpiece and cartridge for improving the appearance of cellulite.
The FDA-clearance was based on positive data from an institutional board-reviewed multi-centre study of 50 women with Fitzpatrick skin types I-III with undulation regularities in the thighs.
They were treated with Profound using the SubQ cartridge and handpiece. There was improvement reported in cellulite severity in dimples and/or undulation irregularities in 94% of treated thighs at a three month follow-up. At the six-month follow-up, sustained improvement was observed in 93% of the treated thighs.
There were similar results per patient, with 88% of the treated patients displaying improvement in the appearance of cellulite at the three month follow-up, and 86% of the treated patients experiencing improvement at six months.
“There has been an increased demand for treatments that can impact the appearance of cellulite over the past few years as it’s a driver of insecurities in both men and women,” said Dr Macrene Alexiades, associate clinical professor at Yale University School of Medicine, and director and president of the Dermatology & Laser Surgery Center of New York. “Profound is an optimal treatment for patients with cellulite who are apprehensive about invasive procedures, as well as for those who are looking to improve the appearance of areas impacted by cellulite in a single treatment. Some subjects showed improvement starting at one month after treatment.” she added.