US FDA update on Renuvion/J-Plasma device

The U.S. Food and Drug Administration (FDA) has provided another update on the Renuvion/J-Plasma device system by Apyx Medical regarding the use of the device for certain aesthetic skin procedures and an additional FDA clearance for a Renuvion/J-Plasma handpiece.

The FDA recommends healthcare providers be aware of the current indications and instructions for the use of the Renuvion/J-Plasma system and handpieces.

• 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 healthcare 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?put through the Renuvion Dermal Handpiece for the treatment of moderate to severe wrinkles and rhytides, limited to patients with?Fitzpatrick Skin TypesExternal Link Disclaimer
• ?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.
• In July 2022,?we informed consumers and health care providers about the FDA clearance of 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.?

It is an important update for consumers and healthcare providers to know about additional FDA clearance for a Renuvion/J-Plasma handpiece that can be used under the skin in certain procedures intended to improve the appearance of the skin.

On April 27, 2023,?the FDA cleared the Renuvion APR handpiece for coagulation of subcutaneous soft tissues following liposuction for aesthetic body contouring.?The labelling and training for the Renuvion APR Handpiece will include detailed instructions for use and important safety information specific to this intended use.

Recommendations for Consumers

• Discuss the benefits and risks of all available aesthetic skin procedures (procedures intended to improve the appearance of the skin) with your health care provider.
• If you are considering any aesthetic skin procedure, ask which devices your provider will use during the procedure.

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.
• Read and carefully follow the Instructions for Use (IFU) and training for the Renuvion/J-Plasma system and handpieces, as these include important safety information.
• Be aware of the current indications for the Renuvion APR Handpiece:?
• The Renuvion APR Handpiece is intended for the delivery of radiofrequency energy and/or helium plasma where coagulation/contraction of soft tissue is needed. Soft tissue includes subcutaneous tissue.?
• The Renuvion APR Handpiece is intended for the coagulation of subcutaneous soft tissues following liposuction for aesthetic body contouring.?
• The Renuvion APR Handpiece is indicated for use in subcutaneous dermatological and aesthetic procedures to improve the appearance of lax (loose) skin in the neck and submental region.?
• The Renuvion APR Handpiece is intended for the delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue during open surgical procedures.
• The Renuvion APR Handpiece is intended to be used with compatible electrosurgical generators owned by Apyx Medical.
• Be aware that a separate handpiece, the Renuvion Dermal Handpiece, is indicated for the treatment of moderate to severe wrinkles and rhytides in patients with Fitzpatrick Skin Types I, II, or III.

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).?

FDA-approved indications for this technology include cutting, coagulation and ablation of soft tissue during open and laparoscopic surgical procedures.?

In Australia, such a device is classified as a Medical Device Class IIb and used with Radiofrequency for dermis application, not topical. A registered doctor should only use it. Designed to be used in conjunction with liposuction procedures, it can be used for skin tightening in the dermis without lipo.?

Such is not the same as Plaxpot ARTG (no: 326840) and other similar devices approved as a Medical Device Class IIb. Such devices used nitrogen plasma. The approved use is different in these cases as used on the surface of the epidermis, not under it. As such non-medical qualified practitioners can use the device. Such 'plasma pens' are not as powerful as helium machines and are used very differently.?

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