Apyx Medical Corp., the manufacturer of the proprietary Renuvion technology, announces that it has received U.S. FDA 510(k) clearance for the use of the Renuvion APR Handpiece for coagulation of subcutaneous soft tissues following liposuction for aesthetic body contouring. This is a significant development for the company, as the Renuvion APR handpiece is the only device to have received clearance for use following liposuction, Apyx officials say.
The CEO and president of Apyx Medical Corp., Charlie Goodwin, expresses his satisfaction at receiving the clearance, stating that it demonstrates the safety and effectiveness of their Renuvion technology. He also acknowledged the work of the company’s regulatory and clinical teams in securing clearances for specific clinical indications. In the past 12 months, the company has received four 510(k) clearances for the use of its Renuvion handpieces in various clinical indications, all of which are supported by evidence demonstrating the safety of the products, according to Goodwin.
Goodwin also mentions that the company believes it now has the necessary 510(k) clearances to resolve the remaining limitations of the FDA Safety Communication. This suggests that Apyx Medical Corporation is confident in its ability to expand the adoption and utilization of its Renuvion technology for specific clinical indications, and to empower surgeons and physicians to achieve the clinical results they desire, Goodwin adds.
Apyx Medical’s Renuvion technology combines helium plasma and radiofrequency energy to deliver controlled heat to soft tissue. This allows for the coagulation of tissue and the tightening of skin, making it suitable for aesthetic body contouring procedures like liposuction. The technology has been shown to be safe and effective in various clinical studies, and its approval by the FDA further reinforces its credibility, according to Apyx officials.