Sam Brusco, Associate Editor02.03.23
Apyx Medical, maker of the Renuvion helium plasma and radiofrequency tech, recently submitted a 510(k) application for the Renuvion APR handpiece to the U.S. Food and Drug Administration (FDA).
The submission was supported by a clinical study and real-world evidence. The submission aims to expand Renuvion’s indication to include coagulation of subcutaneous soft tissues when needed, after liposuction.
“We are pleased to announce the submission of this request for 510(k) clearance for a new clinical indication, which is intended to enable Apyx Medical to market and sell our Renuvion APR Handpiece for use following liposuction,” Charlie Goodwin, president and CEO of Apyx, told the press. “This 510(k) submission leverages the substantial history of safe use of the Renuvion APR handpiece following liposuction procedures, and as such, Apyx Medical was able to assess the device based on a large set of retrospective chart reviews. Importantly, our analysis of Renuvion treatment adverse events, when compared to the real-world evidence gathered for liposuction treatments in the literature review, demonstrated that there are no new or increased risks for Renuvion procedures following liposuction procedures compared to liposuction alone.”
Goodwin continued: “We appreciate the continued engagement from the FDA in recent months as we prepared this important 510(k) submission, and we continue to believe the receipt of 510(k) clearance for this new clinical indication would directly address the remaining limitations of the Medical Device Safety Communication. We look forward to, and support, the FDA’s continued focus on ensuring that everyone in the industry is adhering to the safe and effective use of cosmetic surgery technologies, especially those used during or after liposuction procedures.”
The submission was supported by a clinical study and real-world evidence. The submission aims to expand Renuvion’s indication to include coagulation of subcutaneous soft tissues when needed, after liposuction.
“We are pleased to announce the submission of this request for 510(k) clearance for a new clinical indication, which is intended to enable Apyx Medical to market and sell our Renuvion APR Handpiece for use following liposuction,” Charlie Goodwin, president and CEO of Apyx, told the press. “This 510(k) submission leverages the substantial history of safe use of the Renuvion APR handpiece following liposuction procedures, and as such, Apyx Medical was able to assess the device based on a large set of retrospective chart reviews. Importantly, our analysis of Renuvion treatment adverse events, when compared to the real-world evidence gathered for liposuction treatments in the literature review, demonstrated that there are no new or increased risks for Renuvion procedures following liposuction procedures compared to liposuction alone.”
Goodwin continued: “We appreciate the continued engagement from the FDA in recent months as we prepared this important 510(k) submission, and we continue to believe the receipt of 510(k) clearance for this new clinical indication would directly address the remaining limitations of the Medical Device Safety Communication. We look forward to, and support, the FDA’s continued focus on ensuring that everyone in the industry is adhering to the safe and effective use of cosmetic surgery technologies, especially those used during or after liposuction procedures.”