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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

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

The U.S. Food and Drug Administration (FDA) is warning consumers and health care providers against the use of the Renuvion/J-Plasma device by Apyx Medical 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”).

The use of this device has not been determined to be safe or effective for any procedure intended to improve the appearance of the skin. The FDA has received reports describing serious and potentially life-threatening adverse events with use of this device for certain aesthetic procedures.

This safety communication provides:

• Recommendations for consumers.
• Recommendations for health care providers.
• Background and risks associated with the issue.
• Instructions for reporting problems with theRenuvion/J-Plasma device to the FDA.

Questions?

If you have questions about this safety communication, contact the Division of Industry and Consumer Education (DICE).