FDA: Do Not Use Renuvion/J-Plasma Device for Skin Improvement Procedures

The Renuvion/J-Plasma device by Apyx Medical should not be used to perform certain aesthetic skin procedures, according to a safety communication issued by the Food and Drug Administration (FDA).

The Renuvion/J-Plasma system by Apyx Medical, which includes the Plasma/RF Handpiece and Plasma Generators, are medical devices cleared for general surgery procedures. These devices, which produce a gas-like substance with high heat, can be used for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.

According to the Agency, use of the device for procedures intended to improve the appearance of the skin, including dermal resurfacing or skin contraction, alone or in combination with liposuction, has been associated with significant adverse events, some of which have required treatment in an intensive care unit. Based on reports, these events have included second- and third-degree burns, infection, skin color changes, scars, nerve damage, bleeding, and air or gas accumulation under the skin, in body cavities, and in blood vessels.

The FDA is recommending that health care providers cease using Renuvion/J-Plasma for these types of procedures, as the device is not cleared or approved for use in this setting. Clinicians are also advised to inform patients of the devices that will be used for aesthetic procedures so that the benefits and risks can be discussed.

Additionally, the FDA encourages the reporting of adverse events related to medical devices through the MedWatch Voluntary Reporting Form.

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