510(k) Report

Devices descending from K134054

39 later devices reach Bovie Ids-310 High Frequency Electrosurgical Generator, Aaron A3350 High… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240975Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300)Beijing Taktvoll Technology Co., Ltd.20240—
+1K183611Soniquence RF Generator and Soniquence ElectrodesSoniquence, LLC20195—
+1K170107Surgi Max UltraElliquence, LLC20177—
+1K162656ESU-1 Electrosurgical GeneratorTva Medical, Inc.20161—
+1K161134Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator…Bovie Medical Corporation201614—
+1K142975Bovie Ultimate High Frequency Electrosurgical GeneratorBovie Medical Corporation201412—
+2K254220Reusable 3 Button Fingerswitch WandSoniquence, LLC20260—
+2K222793WavelinQ™ GeneratorC.R. Bard, Inc.20220—
+2K212222Soniquence Reusable 3 Button Fingerswitch WandSoniquence, LLC20221—
+2K202106Plasmage SystemBrera Medical, Inc.20220—
+2K220071Soniquence Reusable Neutral PlateSoniquence, LLC20220—
+2K202562Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and Tips…Ellusa, LLC20201—
+2K192813Plasma IQNeauvia North America, Inc.202012—
+2K170054iSurgJaco, LLC Dba Macan Manufacturing and Bna Burz North America20170—
+2K170188Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency…Bovie Medical Corporation2017116
+3K222425Ellusa Reusable Neutral PlatesEllusa, LLC20220—
+3K210693Plexr PlusGmv S.R.L.20221—
+3K212329Plasma IQNeauvia North America, Inc.20215—
+3K201738SubNovii Advanced Plasma TechnologyCartessa Aesthetics20205—
+3K192867Apyx Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3)Bovie Medical Corporation Dba Apyx Medical Corporation20191—
+3K191542Apyx Plasma/RF HandpieceBovie Medical Corporation Dba Apyx Medical Corporation20194—
+3K183610Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces…Bovie Medical Corporation201961
+3K170777Bovie J-Plasma Precise FLEX HandpieceBovie Medical Corporation20171—
+4K242286Superflow Prime Treatment System (ASP-1M)Guangzhou Aimira Innovation Technology Co, Ltd.20240—
+4K233123SilkroHironic Co., Ltd.20241—
+4K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+4K220493Plaxpot Multi PlasmaGcs Co. Limited20230—
+4K223440Plasma Pen (Plasma MD); Plasma Pen (Plasma +)Plasma Concepts20230—
+4K223222Plasma IQNeauvia North America, Inc.20233—
+4K221830Apyx One ConsoleApyx Medical Corporation20220—
+4K220970Renuvion APR HandpieceApyx Medical Corporation (Formerly Bovie Medical Corporation)20223—
+4K202880J-Plasma Precise FLEX HandpieceApyx Medical Corporation (Formerly Bovie Medical Corporation20210—
+4K191484Renuvion/J-Plasma Precise HandpieceApyx Medical Corporation (Formerly Bovie Medical Corporation)20190—
+5K251334New Doublo 2.0Hironic Co., Ltd.20250—
+5K241099Plasonic (Plasonic)Hironic Co., Ltd.20242—
+5K230272Renuvion® APR HandpieceApyx Medical Corporation20231—
+5K223262Renuvion® APR HandpieceApyx Medical Corporation20232—
+6K260397SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)Hironic Co., Ltd.20260—
+6K230586Renuvion® Micro HandpieceApyx Medical Corporation20230—