FDA 510(K) clearance for the use of Renuvion cosmetic technology in dermal resurfacing procedures.- Apyx Medical Corporation
Apyx Medical Corporation, a maker of medical devices and supplies and the developer of Helium Plasma Technology, marketed and sold as Renuvion and J-Plasma in surgical markets, announced it has received 510(k) clearance from the FDA for the use of the Renuvion Dermal Handpiece for specific dermal resurfacing procedures.
The Renuvion Dermal Handpiece is indicated for dermatological procedures for the treatment of moderate to severe wrinkles and rhytides, limited to patients with Fitzpatrick skin types I, II or III.
The Renuvion system is intended to be used with compatible electrosurgical generators for the delivery of radiofrequency energy and/or helium plasma to cut, coagulate and ablate soft tissue during open surgical procedures. The Apyx Plasma/RF Handpiece (APR HP) is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. The Renuvion system has received a general clearance and has not been determined to be safe or effective for use in any specific indication or anatomical location.
The Renuvion Dermal Handpiece is indicated for dermatological procedures for the treatment of moderate to severe wrinkles and rhytides, limited to patients with Fitzpatrick skin types I, II or III.
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