Date Issued: July 21, 2022
The U.S. Food and Drug Administration (FDA) is providing another update on the Renuvion/J-Plasma device system by Apyx Medical about use of the device for certain aesthetic skin procedures.
- 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 (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, we informed 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.
Today, we are informing consumers and health care providers about 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. The labeling and training for the Renuvion APR Handpiece will include updated instructions for device power settings and treatment parameters specific to use in procedures under the skin for the neck and chin regions. It is important to note that use of the Renuvion APR Handpiece has not been cleared or approved for use in any other aesthetic skin procedure, or in combination with liposuction. The FDA will continue to monitor reports of adverse events with use of Renuvion/J-Plasma for aesthetic skin procedures.
Recommendations for Consumers
The FDA continues to recommend that consumers:
- Discuss the benefits and risks of all available aesthetic skin procedures with your health care provider.
- If you are considering any aesthetic skin procedure, ask which devices your provider will use during the procedure.
- Be aware that the use of Renuvion/J-Plasma to improve the appearance of the skin in combination with liposuction has not been cleared or approved by the FDA. If you are considering liposuction, ask whether your provider plans to use Renuvion/J-plasma during the procedure.
- If you experience any problems or are concerned after a procedure using Renuvion/J-Plasma, seek care from a licensed health care provider.
- Report any problems or complications experienced from procedures with Renuvion/J-Plasma to the FDA. Your report, along with information from other sources, can provide information that helps improve patient safety.
Recommendations for Health Care Providers
Health care providers should review the current FDA recommendations for use of Renuvion/J-Plasma for aesthetic skin procedures:
- Discuss the benefits and risks of all available aesthetic skin procedures with your patient. If you are performing an aesthetic procedure, inform your patient which devices you plan to use.
- Be aware that the Renuvion APR Handpiece has been cleared by the FDA for use in subcutaneous dermatological and aesthetic procedures to improve the appearance of lax (loose) skin in the neck and submental regions.
- Be aware that a separate handpiece, the Renuvion Dermal Handpiece, has been cleared by the FDA for the treatment of moderate to severe wrinkles and rhytides in patients with Fitzpatrick Skin Types I, II, or III.
- Be aware that Renuvion/J-Plasma has not been determined to be safe or effective for any other aesthetic skin procedures.
- Do not use Renuvion/J-Plasma to improve the appearance of the skin in combination with liposuction.
- Report any problems or complications experienced by patients from procedures with Renuvion/J-Plasma to the FDA.
Device Description
The Renuvion/J-Plasma system by Apyx Medical 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 Renuvion/J-Plasma handpieces (Renuvion APR (Apyx Plasma/RF) handpiece, Renuvion/J-Plasma Precise and Precise Open handpieces) can be used to cut, coagulate (stop bleeding), and eliminate soft tissue with heat during surgery.
The Renuvion APR handpiece can also be used under the skin to improve the appearance of loose skin in the neck and chin regions only. The Renuvion APR Handpiece has not been cleared or approved for use in any other aesthetic skin procedure, or in combination with liposuction. 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.
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.
FDA Actions
The FDA continues to work with the manufacturer to evaluate all available information about the use of Renuvion/J-Plasma for aesthetic skin procedures.
The FDA will continue to monitor reports of adverse events. The FDA will keep the public informed if significant new information becomes available.
Reporting Problems with Your Device
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.
Questions?
If you have questions, email the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV or call 800-638-2041 or 301-796-7100.
