The FDA last week provided another update on the Renuvion/J-Plasma device system by Apyx Medical regarding use of the device for certain aesthetic skin procedures and an additional FDA clearance for a Renuvion/J-Plasma handpiece.
The system is a medical device that includes a handpiece and plasma generator. The system uses radiofrequency (RF) energy and helium to generate plasma (gas-like substance with high heat).
The FDA recommends that health care providers be aware of the current indications and instructions for use for the Renuvion/J-Plasma system and handpieces.
In March 2022, the FDA warned against the use of the Renuvion/J-Plasma for procedures intended to improve the appearance of the skin through dermal resurfacing (a procedure on the skin to treat wrinkles) or skin contraction (a procedure under the skin that can be performed either alone or in combination with liposuction to achieve skin effects, such as "tightening").
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 (procedures intended to improve the appearance of the skin).
In June 2022, the FDA told consumers and health care providers about the FDA clearance of a new handpiece for the Renuvion/J-Plasma device system that can be used for certain dermal resurfacing 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.
In July 2022, the FDA informed consumers and health care providers about the FDA clearance of a Renuvion/J-Plasma handpiece that can be used under the skin in certain procedures intended to improve the appearance of loose skin. 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 (loose) skin in the neck and submental (under the chin) region.
Now, the FDA is are informing consumers and health care providers about an additional FDA clearance for a Renuvion/J-Plasma handpiece that can be used under the skin in certain procedures intended to improve the appearance of the skin.
On April 27, 2023, the FDA cleared the Renuvion APR handpiece for coagulation of subcutaneous soft tissues following liposuction for aesthetic body contouring. The labeling and training for the Renuvion APR Handpiece will include detailed instructions for use and important safety information specific to this intended use.
The FDA will continue to work with the manufacturer to monitor reports of adverse events for Renuvion/J-Plasma. The agency will also continue to monitor reports of adverse events for other minimally invasive soft tissue heating devices in aesthetic skin procedures, and work to ensure that consumers and health care providers are informed about the intended uses of these devices.