New Apyx Renuvion J-Plasma Handpiece Available

FDA approved 5/25 the Apyx Renuvion dermal handpiece to be used with the company’s medical helium plasma generator for treating moderate to severe wrinkles and rhytides. A 6/2 updated agency safety communication says the new handpiece is limited to patients with Fitzpatrick skin types I, II, or III.

The labeling and training for the new handpiece include instructions for device power settings and the number of treatment passes, the communication says. That is separate, it says, from existing Renuvion/J-Plasma handpieces that are cleared for general use of cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.

FDA says it continues to warn against using the Renuvion/J-Plasma for procedures intended to improve the appearance of the skin through skin contraction, as discussed in a 3/14 safety communication. The agency says it will continue to monitor adverse event reports with the use of the device for esthetic skin procedures.