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

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Date of issue: July 21, 2022

The U.S. Food and Drug Administration (FDA) provides another update on Apyx Medical’s Renuvion/J-Plasma Device System regarding the use of the device for certain skin aesthetic procedures.

  • In March 2022, the FDA warned against the use of Renuvion/J-Plasma for procedures intended to improve the appearance of the skin by dermal resurfacing (a procedure on the skin to treat wrinkles) or contraction of the skin (a procedure under the skin that can be performed alone or in combination with liposuction to achieve skin effects, such as “firming”). At that time, the Renuvion/J-Plasma device system was cleared by the FDA for general use in cutting, coagulation, and soft tissue ablation in open and laparoscopic surgical procedures. The device has not been found to be safe or effective for use in cosmetic skin procedures (procedures intended to improve the appearance of the skin).
  • In June 2022, we notified consumers and healthcare providers of FDA approval of a new handpiece for the Renuvion/J-Plasma Device System that can be used for certain resurfacing procedures. dermal. On May 25, 2022, the FDA erased the Renuvion dermal handpiece for the treatment of moderate to severe lines and wrinkles, limited to patients with Fitzpatrick skin types I, II or III. This new handpiece is distinct from the Renuvion/J-Plasma handpieces which are licensed for general use in cutting, coagulation and soft tissue ablation during open and laparoscopic surgical procedures.

Today we are informing consumers and healthcare providers about a Renuvion/J-Plasma handpiece that can be used under the skin in certain procedures to improve the appearance of loose skin. On July 15, 2022, the FDA erased Renuvion APR Handpiece for use in subcutaneous dermatological and aesthetic procedures to improve the appearance of lax (loose) skin in the neck and submental region (under the chin). Labeling and training for the Renuvion APR handpiece will include updated instructions for device power settings and specific treatment parameters for use in subcutaneous procedures for the neck and chin regions . It is important to note that the use of the Renuvion APR Handpiece has not been authorized 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 associated with the use of Renuvion/J-Plasma for cosmetic skin procedures.

Recommendations for consumers

The FDA continues to recommend that consumers:

  • Discuss the benefits and risks of all available cosmetic skin procedures with your healthcare provider.
  • If you are considering a cosmetic skin procedure, ask which devices your provider will use during the procedure.
  • Please be aware that the use of Renuvion/J-Plasma to improve the appearance of skin in combination with liposuction has not been cleared or approved by the FDA. If you are considering liposuction, ask if your provider plans to use Renuvion/J-plasma during the procedure.
  • If you have any problems or are concerned after a procedure using Renuvion/J-Plasma, consult a licensed health care provider.
  • Report any problems or complications encountered during procedures with Renuvion/J-Plasma at the FDA. Your report, along with information from other sources, can provide information that helps improve patient safety.

Recommendations for Health Care Providers

Healthcare providers should review current FDA recommendations regarding the use of Renuvion/J-Plasma for aesthetic skin procedures:

  • Discuss the benefits and risks of all available cosmetic skin procedures with your patient. If you are performing a cosmetic procedure, inform your patient of the 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 approved by the FDA for the treatment of moderate to severe wrinkles and wrinkles in patients with Fitzpatrick I, II, or III skin types.
  • Please be aware that Renuvion/J-Plasma has not been determined to be safe or effective for any other aesthetic skin procedure.
  • 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 following procedures with Renuvion/J-Plasma at the FDA.

Description of the device

The Renuvion/J-Plasma system from Apyx Medical is a medical device that includes a handpiece and a plasma generator. The system uses radio frequency (RF) energy and helium to generate plasma (a high temperature gas-like substance). 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 remove soft tissues 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 areas 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 life-threatening adverse events after using the device for procedures intended to improve the appearance of the skin by skin contraction in combination with liposuction.

A separate handpiece, the Renuvion Dermal Handpiece, can be used to treat moderate to severe fine lines and wrinkles in patients with Fitzpatrick I, II and III skin types. Use of the Renuvion Dermal Handpiece has not been found to be safe or effective for all dermal resurfacing procedures or in patients with Fitzpatrick skin types IV, V, or VI.

FDA measures

The FDA continues to work with the manufacturer to evaluate all available information on the use of Renuvion/J-Plasma for cosmetic 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.

Report problems with your device

If you believe you have had a problem with your device, the FDA encourages you to report the problem via the MedWatch voluntary reporting form.

Healthcare personnel employed by facilities subject to FDA user facility reporting requirements must follow the reporting procedures established by their facilities.

Questions?

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

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