510(k) Report

Devices descending from K170188

11 later devices reach Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192867Apyx Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3)Bovie Medical Corporation Dba Apyx Medical Corporation20191—
+1K191542Apyx Plasma/RF HandpieceBovie Medical Corporation Dba Apyx Medical Corporation20194—
+1K183610Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces…Bovie Medical Corporation201961
+1K170777Bovie J-Plasma Precise FLEX HandpieceBovie Medical Corporation20171—
+2K221830Apyx One ConsoleApyx Medical Corporation20220—
+2K220970Renuvion APR HandpieceApyx Medical Corporation (Formerly Bovie Medical Corporation)20223—
+2K202880J-Plasma Precise FLEX HandpieceApyx Medical Corporation (Formerly Bovie Medical Corporation20210—
+2K191484Renuvion/J-Plasma Precise HandpieceApyx Medical Corporation (Formerly Bovie Medical Corporation)20190—
+3K230272Renuvion® APR HandpieceApyx Medical Corporation20231—
+3K223262Renuvion® APR HandpieceApyx Medical Corporation20232—
+4K230586Renuvion® Micro HandpieceApyx Medical Corporation20230—