FDA Clears Renuvion APR Handpiece for Coagulation of Subcutaneous Soft Tissues after Liposuction for Body Contouring

The U.S. Food and Drug Administration (FDA) cleared the Renuvion APR Handpiece for coagulation of subcutaneous soft tissues following liposuction for aesthetic body contouring.

“The Renuvion APR handpiece is the only device to have a 510(k) clearance for use following liposuction,” says Charlie Goodwin, President and Chief Executive Officer, in a news release. “This 510(k) clearance further demonstrates the safety and effectiveness of our Renuvion technology, and our continued commitment to working with the FDA to secure specific clinical indications.”

In the last year, the Company received four 510(k) clearances for the use of our Renuvion handpieces in specific clinical indications.

The company now has the required 510(k) clearances to resolve the remaining limitations of the FDA Safety Communication. The FDA had received reports describing serious and potentially life-threatening adverse events after the device was used for procedures intended to improve the appearance of the skin through skin contraction in combination with liposuction. In March 2022, the FDA warned against the use of Renuvion/J-Plasma for procedures intended to improve the appearance of the skin through dermal resurfacing or skin contraction alone or in combination with liposuction to achieve skin effects.

“We believe we now have the requisite 510(k) clearances to resolve the remaining limitations of the FDA Safety Communication,” Goodwin says.