510(k) Report

Devices descending from K871435

18 later devices reach Bard Ems System 6000 E.S.U. through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K030819Plasmajet SystemPlasma Surgical, Ltd.200417—
+2K090586Bovie Icon GS Electrosurgical Generator (GS100), Handpiece (GS-OP-R), Reusable Handpiece…Bovie Medical200916—
+3K142975Bovie Ultimate High Frequency Electrosurgical GeneratorBovie Medical Corporation201412—
+3K112233Bovie J-Plasma Handpiece with Retractable Cutting BladeBovie Medical Corporation201214—
+4K170188Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency…Bovie Medical Corporation2017116
+4K151325Bovie J-Plasma HandpieceBovie Medical Corporation2015131
+5K192867Apyx Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3)Bovie Medical Corporation Dba Apyx Medical Corporation20191—
+5K191542Apyx Plasma/RF HandpieceBovie Medical Corporation Dba Apyx Medical Corporation20194—
+5K191484Renuvion/J-Plasma Precise HandpieceApyx Medical Corporation (Formerly Bovie Medical Corporation)20190—
+5K183610Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces…Bovie Medical Corporation201961
+5K170777Bovie J-Plasma Precise FLEX HandpieceBovie Medical Corporation20171—
+5K152570Bovie J-Plasma Precise 360 HandpieceBovie Medical Corporation2015125
+6K221830Apyx One ConsoleApyx Medical Corporation20220—
+6K220970Renuvion APR HandpieceApyx Medical Corporation (Formerly Bovie Medical Corporation)20223—
+6K202880J-Plasma Precise FLEX HandpieceApyx Medical Corporation (Formerly Bovie Medical Corporation20210—
+7K230272Renuvion® APR HandpieceApyx Medical Corporation20231—
+7K223262Renuvion® APR HandpieceApyx Medical Corporation20232—
+8K230586Renuvion® Micro HandpieceApyx Medical Corporation20230—