FDA updates recommendations for use of Renuvion/J-Plasma device

Renuvion/J-Plasma device with new handpiece can be used for certain aesthetic skin procedures.

If your email program has trouble displaying this email, view as a webpage. FDA Updates Recommendations for the Use of Renuvion/J-Plasma Device for Certain Aesthetic Procedures: FDA Safety Communication Today, 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 that has been FDA cleared for use with the Renuvion/J-Plasma device system by Apyx Medical. The Renuvion Dermal Handpiece can be used for the treatment of moderate to severe wrinkles and rhytides in patients with Fitzpatrick Skin Types I, II, or III. The Renuvion/J-Plasma device system has not been determined to be safe or effective for any other aesthetic skin procedures. Read More This safety communication update provides: Recommendations for consumers. Recommendations for health care providers. Background on the issue. Instructions for reporting problems with the Renuvion/J-Plasma device to the FDA. Questions? If you have questions about this safety communication, contact the Division of Industry and Consumer Education.

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