FDA Warns Against Use of Renuvion/J

The FDA has provided updates to this safety communication:

July 21, 2022 - UPDATE: Use of Renuvion/J-Plasma Device for Certain Aesthetic Procedures: FDA Safety Communication

June 2, 2022 - UPDATE: FDA Updates Recommendations for the Use of Renuvion/J-Plasma Device for Certain Aesthetic Procedures: FDA Safety Communication

Date Issued: March 14, 2022

The U.S. Food and Drug Administration (FDA) is warning consumers and health care providers against the use of the Renuvion/J-Plasma device by Apyx Medical for certain aesthetic procedures. Specifically, the FDA is warning against the use 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").

The Renuvion/J-Plasma device is FDA cleared for general use of cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures. The use of this device has not been determined to be safe or effective for any specific procedure intended to improve the appearance of the skin. The FDA has received reports describing serious adverse events when the Renuvion/J-plasma device was used directly on the skin and potentially life-threatening adverse events when the Renuvion/J-plasma device was used under the skin.

The Renuvion/J-Plasma system by Apyx Medical, which includes the Plasma/RF Handpiece and Plasma Generators, are medical devices cleared for general surgery procedures. These devices use radiofrequency (RF) energy and helium to generate plasma (gas-like substance with high heat). The plasma can be used to cut, coagulate (stop bleeding), and eliminate soft tissue with heat during surgery. The use of the device has not been determined to be safe or effective in any specific procedures, including aesthetic skin procedures.

The FDA has received reports describing serious and potentially life-threatening adverse events after the device was used for aesthetic skin procedures. Reported events include second- and third- degree burns, infection, change in skin color, scars, nerve damage, significant bleeding, and air or gas accumulation under the skin, in body cavities, and in blood vessels. In some cases, adverse events required treatment in an intensive care unit (ICU).

The FDA is working with the manufacturer to evaluate all available information about the use of Renuvion/J-Plasma for aesthetic skin procedures and to inform patients and providers that the device has not been determined to be safe or effective for these procedures.

The FDA will continue to monitor reports of adverse events. The FDA will keep the public informed if significant new information becomes available.

If you think you had a problem with your device, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.

Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

If you have questions, email the Division of Industry and Consumer Education (DICE) at [email protected] or call 800-638-2041 or 301-796-7100.

07/21/2022