July 21, 2022 – UPDATE: The FDA provided an update to this safety communication. Read “Use of Renuvion/J-Plasma Device for Certain Aesthetic Procedures: FDA Safety Communication” for the latest information.
Date Issued: June 2, 2022
The U.S. Food and Drug Administration (FDA) is updating our safety communication issued in March 2022 to inform consumers and health care providers about a new handpiece for the Apyx Renuvion/J-Plasma device system that can be used for certain aesthetic skin procedures. On May 25, 2022, the FDA cleared the Renuvion Dermal Handpiece to be used with the Apyx Medical Helium Plasma Generator for the treatment of moderate to severe wrinkles and rhytides, limited to patients with Fitzpatrick Skin Types I, II or III. The labeling and training for the new handpiece include instructions for device power settings and number of treatment passes. This is separate from existing Renuvion/J-Plasma handpieces that are cleared for general use of cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.
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. In addition, the FDA continues to warn against the use of Renuvion/J-Plasma for procedures intended to improve the appearance of the skin through skin contraction (a procedure under the skin that is performed either alone or in combination with liposuction to achieve skin effects, such as “tightening”). The FDA will continue to monitor reports of adverse events with use of the device for aesthetic skin procedures.
Recommendations for 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 for procedures intended to improve the appearance of the skin through skin contraction (a procedure under the skin that is performed either alone or in combination with liposuction to achieve skin effects, such as “tightening”) 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
- 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 a new handpiece, the Renuvion Dermal Handpiece, has been cleared by the FDA to be used with Apyx Medical Helium Plasma Generators for the treatment of moderate to severe wrinkles and rhytides in patients with Fitzpatrick Skin Types I, II, or III.
- Be aware that existing Renuvion/J-Plasma handpieces are cleared for the general use of cutting, coagulation and ablation of soft tissue during open and laparoscopic surgical procedures.
- Do not use Renuvion/J-Plasma for skin contraction, alone or in combination with liposuction.
- Be aware that the use of Renuvion/J-Plasma for skin contraction may result in serious and potentially life-threatening adverse events.
- 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 existing 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. A separate, new 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 Renuvion/J-Plasma device system has not been determined to be safe or effective for any other aesthetic skin procedures.
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 (a procedure under the skin that is performed either alone or in combination with liposuction to achieve skin effects, such as “tightening”). 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 continues to warn against the use of Renuvion/J-Plasma for skin contraction, alone or in combination with liposuction.
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.