Apyx Medical Earns 510(k) Clearance for the Apyx Plasma/RF Handpiece
The FDA granted Apyx Medical Corp. 510(k) clearance for its Apyx Plasma/RF Handpiece, a new addition to its Renuvion line of cosmetic and hospital surgery products.
The agency cleared the handpiece as a single use device for delivery of radiofrequency energy or helium plasma for cutting, coagulation and ablation of soft tissue. The new model features a smaller diameter instrument shaft, a bullet-shaped instrument tip that directs the flow of plasma energy from ports on the side of the instrument tip, as opposed to the front of the instrument tip.
The handpiece includes features to help minimize unwanted energy application near the incision entry site. Specifically, each handpiece configuration has distance indicators on its tip and will be sold with accompanying epidermal marking templates to help surgeons determine the proximity of the device tip to the entry of the insertion site.