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

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Issue date: June 2, 2022

The U.S. Food and Drug Administration (FDA) is updating its Safety Communication issued in March 2022 to inform consumers and healthcare providers of a new handpiece for the Apyx Renuvion Device System/ J-Plasma which can be used for certain aesthetic skin procedures. On May 25, 2022, the FDA cleared the Renuvion Dermal Handpiece for use with the Apyx Medical Helium Plasma Generator for the treatment of moderate to severe lines and wrinkles, limited to patients with Fitzpatrick I skin type, II or III. Labeling and training for the new handpiece includes instructions for device power settings and number of treatment passes. This is distinct from existing Renuvion/J-Plasma handpieces which are cleared for general use in cutting, coagulation and soft tissue ablation during open and laparoscopic surgical procedures.

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. Additionally, the FDA continues to caution against the use of Renuvion/J-Plasma for procedures intended to improve the appearance of the skin by skin contraction (a procedure under the skin that is performed alone or in combination with liposuction to achieve skin effects, such as “tightening”). The FDA will continue to monitor adverse event reports related to the use of the device for cosmetic skin procedures.

Recommendations for 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.
  • Be aware that using 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 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 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 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 a new handpiece, the Renuvion Dermal Handpiece, has been cleared by the FDA for use with Apyx Medical Helium Plasma Generators for the treatment of moderate to severe lines and wrinkles in patients with Fitzpatrick skin type I, II or III.
  • Be aware that existing Renuvion/J-Plasma handpieces are cleared for general use in cutting, coagulation and soft tissue ablation during open and laparoscopic surgical procedures.
  • Do not use Renuvion/J-Plasma for skin contraction alone or in combination with liposuction.
  • Be aware that using Renuvion/J-Plasma for skin tightening can cause serious and life-threatening side effects.
  • Report any problems or complications experienced by patients following procedures with Renuvion/J-Plasma to 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). 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 tissues with heat during surgery. A distinct new Renuvion dermal handpiece can be used to treat moderate to severe lines and wrinkles in patients with Fitzpatrick I, II and III skin types. The Renuvion/J-Plasma device system has not been determined to be safe or effective for any other cosmetic skin procedure.

The FDA has received reports describing serious and life-threatening adverse events following use of the device for procedures intended to improve the appearance of the skin by skin contraction (a procedure under the skin that is performed alone or in combination with a liposuction to achieve skin effects, such as “firming”). Reported events include second and third degree burns, infection, change in skin color, scarring, nerve damage, severe bleeding, and accumulation of air or gas under the skin, in the body cavities and blood vessels. In some cases, adverse events required treatment in an intensive care unit (ICU). The FDA continues to caution against using Renuvion/J-Plasma for skin contraction alone or in combination with liposuction.

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 adverse event reports. 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 through 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 DICE@FDA.HHS.GOV or call 800-638-2041 or 301-796- 7100.

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