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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

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

Today, the U.S. Food and Drug Administration (FDA) is providing another update on the Renuvion/J-Plasma device system by Apyx Medical to inform consumers and health care providers about a handpiece that has been FDA cleared for use under the skin in certain procedures intended to improve the appearance of loose skin.

The Renuvion APR Handpiece can be used in subcutaneous dermatological and aesthetic procedures to improve the appearance of loose skin in the neck and submental (under the chin) region. The Renuvion APR Handpiece has not been cleared or approved for use in any other aesthetic skin procedure, or in combination with liposuction.  

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 (DICE).