FDA Releases Update on Additional Renuvion/J-Plasma Device Use

As of May 25, the FDA approved the use of the Renuvion Dermal Handpiece/J-Plasma device paired with the Apyx Medical Helium Plasma Generator specifically for the treatment of moderate to severe wrinkles and rhytides.¹ Treatment is available to patients with Fitzpatrick Skin types I, II, or III. The FDA updated its safety communication from March 2022 to inform patients and healthcare providers about the updated use of the Renuvion/J-Plasma device (Apyx Medical).

While the Renuvion/J-Plasma device is cleared to treat wrinkles and rhytides, it is not approved as safe or effective for all dermal resurfacing treatments. Patients with Fitzpatrick skin types IV, V, or VI are not approved to receive treatments via the Renuvion Dermal Handpiece. The FDA warns against the use of Renuvion/J-Plasma for dermal procedures that are meant to improve the appearance of skin through skin contraction.

The newly approved treatment method uses a combination of helium plasma and radiofrequency (RF) energy to treat wrinkles or those with Fitzpatrick skin types I, II, and III. Those who receive or perform the procedure should be aware of potentially life-threatening AEs. The FDA has received reports of serious AEs after the Renuvion device was used to improve skin appearance through contraction. Some reports include second and third-degree burns, infections, scars, nerve damage, and bleeding.

In issuing this approval, The FDA continues to discourage the use of Renuvion/J-Plasma for skin contraction by itself or used in conjunction with liposuction. In the meantime, the FDA recommends patients and healthcare providers should consider the following recommendations before treatment¹:

• Discuss the benefits and risks of all available aesthetic skin procedures
• Consider which device would be best for individual needs
• Determine if Renuvion/J-Plasma is necessary if the patient also receives liposuction
• Report any concerns after the procedure to the healthcare provider
• Notify the FDA of any complications

The FDA will continue to monitor reports of adverse events (AEs) with Renuvion/J-Plasma device.

Reference:

1. Health C for D and R. Update: fda updates recommendations for the use of renuvion/j-plasma device for certain aesthetic procedures: fda safety communication. FDA. Published online June 2, 2022. Accessed June 9, 2022. https://www.fda.gov/medical-devices/safety-communications/update-fda-updates-recommendations-use-renuvionj-plasma-device-certain-aesthetic-procedures-fda