510(k) Report

Devices descending from K191542

4 later devices reach Apyx Plasma/RF Handpiece through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220970Renuvion APR HandpieceApyx Medical Corporation (Formerly Bovie Medical Corporation)20223—
+2K230272Renuvion® APR HandpieceApyx Medical Corporation20231—
+2K223262Renuvion® APR HandpieceApyx Medical Corporation20232—
+3K230586Renuvion® Micro HandpieceApyx Medical Corporation20230—