FDA Provides Update on Its Safety Notice About Apyx’s Renuvion/J-Plasma

The FDA has issued an update on its March safety recommunication regarding Apyx’s Renuvion/J-Plasma device for use in certain aesthetic skin procedures.

On May 25, the agency says, it cleared the Renuvion dermal handpiece to be used with the Apyx Medical Helium Plasma Generator to treat moderate to severe wrinkles and rhytides (fine lines and creases) in patients with Fitzpatrick Skin Types I, II or III, which include pale, fair and dark white skins.

But the FDA cautioned that use of the Renuvion device may not be safe or effective for all dermal resurfacing procedures or in patients with Fitzpatrick Skin Types IV, V or VI, which cover light brown, brown or black skins.

In addition, the FDA renewed its March warning against using Renuvion/J-Plasma for procedures intended to remove wrinkles, improving the appearance of the skin through dermal resurfacing or skin contraction — a procedure sometimes performed in combination with liposuction.