After earlier this year warning against the use of the Renuvion/J-Plasma device by Apyx Medical for certain aesthetic procedures, the FDA has updated its recommendations for the device.
In March, the FDA warned against the use 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 FDA said it had received reports describing serious adverse events when the Renuvion/J-plasma device was used directly on the skin and potentially life-threatening adverse events when the Renuvion/J-plasma device was used under the skin.
But now the FDA has updated its original safety communication to inform consumers and health care providers about a new handpiece for the Apyx Renuvion/J-Plasma device system that can be used for certain aesthetic skin procedures. In May, the FDA cleared the Renuvion Dermal Handpiece to be used with the Apyx Medical Helium Plasma Generator for the treatment of moderate to severe wrinkles and rhytides, limited to patients with Fitzpatrick Skin Types I, II or III.
