510(k) Report

Devices descending from K083452

55 later devices reach Erbe Model Vio 300 D with Accessories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251108Erbe ESU Model VIO® 3n with AccessoriesErbe Elektromedizin GmbH20250—
+1K214058Beamer AVEO Electrosurgical Generator, Beamer AVEO Argon Module, Beamer AVEO Cart…Conmed Corporation20220—
+1K192342Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare…Hangzhou AGS MedTech Co., Ltd.20200—
+1K192905Creo Electrosurgical System with HS1 Hemostasis AccessoryCreo Medical, Ltd.20200—
+1K190823Erbe ESU Model VIO 3 with AccessoriesErbe Elektromedizin GmbH20192—
+1K180200ESG-300, APU-300, Pressure Reducer, MAPC ProbesOlympus Winter & Ibe GmbH20180—
+1K171983Creo Medical Electrosurgical System including Speedboat RS2 Surgical AccessoryCreo Medical, Ltd.20171—
+1K150364ERBE ESU Model VIO dV with AccessoriesErbe Elektromedizin GmbH20165—
+1K134054Bovie Ids-310 High Frequency Electrosurgical Generator, Aaron A3350 High Frequency…Bovie Medical Corporation201439—
+1K133180Erbe Esu Model Vio DV with AccessoriesErbe USA, Inc.20136—
+2K240975Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300)Beijing Taktvoll Technology Co., Ltd.20240—
+2K240932HybridTherm SystemErbe Elektromedizin GmbH20241—
+2K191280E-100 Electrosurgical Generator, SynchroSealIntuitive Surgical, Inc.201942
+2K183611Soniquence RF Generator and Soniquence ElectrodesSoniquence, LLC20195—
+2K170107Surgi Max UltraElliquence, LLC20177—
+2K162656ESU-1 Electrosurgical GeneratorTva Medical, Inc.20161—
+2K161134Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator…Bovie Medical Corporation201614—
+2K142975Bovie Ultimate High Frequency Electrosurgical GeneratorBovie Medical Corporation201412—
+3K254220Reusable 3 Button Fingerswitch WandSoniquence, LLC20260—
+3K223039da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20223—
+3K222793WavelinQ™ GeneratorC.R. Bard, Inc.20220—
+3K212222Soniquence Reusable 3 Button Fingerswitch WandSoniquence, LLC20221—
+3K202106Plasmage SystemBrera Medical, Inc.20220—
+3K220071Soniquence Reusable Neutral PlateSoniquence, LLC20220—
+3K202562Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and Tips…Ellusa, LLC20201—
+3K192813Plasma IQNeauvia North America, Inc.202012—
+3K170054iSurgJaco, LLC Dba Macan Manufacturing and Bna Burz North America20170—
+3K170188Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency…Bovie Medical Corporation2017116
+4K231212da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20232—
+4K222425Ellusa Reusable Neutral PlatesEllusa, LLC20220—
+4K210693Plexr PlusGmv S.R.L.20221—
+4K212329Plasma IQNeauvia North America, Inc.20215—
+4K201738SubNovii Advanced Plasma TechnologyCartessa Aesthetics20205—
+4K192867Apyx Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3)Bovie Medical Corporation Dba Apyx Medical Corporation20191—
+4K191542Apyx Plasma/RF HandpieceBovie Medical Corporation Dba Apyx Medical Corporation20194—
+4K183610Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces…Bovie Medical Corporation201961
+4K170777Bovie J-Plasma Precise FLEX HandpieceBovie Medical Corporation20171—
+5K242286Superflow Prime Treatment System (ASP-1M)Guangzhou Aimira Innovation Technology Co, Ltd.20240—
+5K241635da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20241—
+5K233123SilkroHironic Co., Ltd.20241—
+5K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+5K220493Plaxpot Multi PlasmaGcs Co. Limited20230—
+5K223440Plasma Pen (Plasma MD); Plasma Pen (Plasma +)Plasma Concepts20230—
+5K223222Plasma IQNeauvia North America, Inc.20233—
+5K221830Apyx One ConsoleApyx Medical Corporation20220—
+5K220970Renuvion APR HandpieceApyx Medical Corporation (Formerly Bovie Medical Corporation)20223—
+5K202880J-Plasma Precise FLEX HandpieceApyx Medical Corporation (Formerly Bovie Medical Corporation20210—
+5K191484Renuvion/J-Plasma Precise HandpieceApyx Medical Corporation (Formerly Bovie Medical Corporation)20190—
+6K253556da Vinci SP Surgical System (SP1098); da Vinci E-200 GeneratorIntuitive Surgical, Inc.20260—
+6K251334New Doublo 2.0Hironic Co., Ltd.20250—
+6K241099Plasonic (Plasonic)Hironic Co., Ltd.20242—
+6K230272Renuvion® APR HandpieceApyx Medical Corporation20231—
+6K223262Renuvion® APR HandpieceApyx Medical Corporation20232—
+7K260397SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)Hironic Co., Ltd.20260—
+7K230586Renuvion® Micro HandpieceApyx Medical Corporation20230—