U.S. FDA: Renuvion Cleared to Coagulate and Contract Soft Tissues, Including Subcutaneous Tissue
The U.S. Food and Drug Administration (FDA) has cleared the use of the Renuvion APR Handpiece for the delivery of radiofrequency energy and/or helium plasma where coagulation/contraction of soft tissue is needed. (Soft tissue includes subcutaneous tissue.)
“We are pleased to receive this 510(k) clearance with specific indication language related to the use of the Renuvion APR Handpiece for the contraction of soft tissues, including subcutaneous tissue, where needed,” says Charlie Goodwin, President and Chief Executive Officer, in a news release.
The company’s 510(k) submission to obtain an additional specific indication for the use of the Renuvion APR Handpiece for the contraction of subcutaneous soft tissues where needed following liposuction remains under review by the FDA.
Other indications, FDA actions
The Renuvion APR handpiece can also be used under the skin to improve the appearance of loose skin in the neck and chin regions. A separate handpiece, the Renuvion Dermal Handpiece, can be used to treat moderate to severe wrinkles and rhytides in patients with Fitzpatrick skin types I, II, and III. The use of the Renuvion Dermal Handpiece has not been determined to be safe or effective for all dermal resurfacing procedures, or in patients with Fitzpatrick Skin Types IV, V, or VI.
The FDA has 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.
At that time, the Renuvion/J-Plasma device system was FDA cleared for general use of cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures. The use of the device had not been determined to be safe or effective for any aesthetic skin procedures.
On May 25, 2022, the FDA cleared the Renuvion Dermal Handpiece for the treatment of moderate to severe wrinkles and rhytides, limited to patients with Fitzpatrick Skin Types I, II or III. This new handpiece is separate from Renuvion/J-Plasma handpieces that are cleared for general use of cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.
On July 15, 2022, the FDA cleared the Renuvion APR Handpiece for use in subcutaneous dermatological and aesthetic procedures to improve the appearance of lax skin in the neck and submental region.
Health care providers should review the current FDA recommendations for use of Renuvion/J-Plasma for aesthetic skin procedures, the FDA notes. Report any problems or complications experienced by patients from procedures with Renuvion/J-Plasma to the FDA.
The FDA continues to work with the manufacturer to evaluate all available information about the use of Renuvion/J-Plasma for aesthetic skin procedures.