510(k) Report

Devices descending from K001382

49 later devices reach Aaron 2100 High Frequency Electrosurgical Generator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K022856Bovie Ids-300 High Frequency Electrosurgical GeneratorAaron Medical Industries200348—
+2K134054Bovie Ids-310 High Frequency Electrosurgical Generator, Aaron A3350 High Frequency…Bovie Medical Corporation201439—
+2K100669Canady Plasma Electrosurgical Unit Series with Accessory Probes and BladesUs Medical Innovations, LLC20112—
+2K082109Bovie Icon General Purpose RF GeneratorBovie Medical20081—
+2K072041Bovie Ids-400 Electrosurgical GeneratorBovie Medical20081—
+2K061884Bovie Icon GI Electrosurgical Generator, Model GI 120Bovie Medical20062—
+3K240975Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300)Beijing Taktvoll Technology Co., Ltd.20240—
+3K192124Canady Plasma SMART XL-1000 Electrosurgical Generator with AccessoriesUs Medical Innovations, LLC20191—
+3K183611Soniquence RF Generator and Soniquence ElectrodesSoniquence, LLC20195—
+3K170107Surgi Max UltraElliquence, LLC20177—
+3K162656ESU-1 Electrosurgical GeneratorTva Medical, Inc.20161—
+3K161134Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator…Bovie Medical Corporation201614—
+3K142975Bovie Ultimate High Frequency Electrosurgical GeneratorBovie Medical Corporation201412—
+3K130760Electrosurgical GeneratorBeijing Jinhengwei Technology Development Co., Ltd.20130—
+3K092383Bovie Icon VS General Purpose RF Generator, Model: VS300Bovie Medical Corporation20100—
+4K254220Reusable 3 Button Fingerswitch WandSoniquence, LLC20260—
+4K240297Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS)Us Medical Innovations, LLC20240—
+4K222793WavelinQ™ GeneratorC.R. Bard, Inc.20220—
+4K212222Soniquence Reusable 3 Button Fingerswitch WandSoniquence, LLC20221—
+4K202106Plasmage SystemBrera Medical, Inc.20220—
+4K220071Soniquence Reusable Neutral PlateSoniquence, LLC20220—
+4K202562Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and Tips…Ellusa, LLC20201—
+4K192813Plasma IQNeauvia North America, Inc.202012—
+4K170054iSurgJaco, LLC Dba Macan Manufacturing and Bna Burz North America20170—
+4K170188Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency…Bovie Medical Corporation2017116
+5K222425Ellusa Reusable Neutral PlatesEllusa, LLC20220—
+5K210693Plexr PlusGmv S.R.L.20221—
+5K212329Plasma IQNeauvia North America, Inc.20215—
+5K201738SubNovii Advanced Plasma TechnologyCartessa Aesthetics20205—
+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—
+5K183610Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces…Bovie Medical Corporation201961
+5K170777Bovie J-Plasma Precise FLEX HandpieceBovie Medical Corporation20171—
+6K242286Superflow Prime Treatment System (ASP-1M)Guangzhou Aimira Innovation Technology Co, Ltd.20240—
+6K233123SilkroHironic Co., Ltd.20241—
+6K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+6K220493Plaxpot Multi PlasmaGcs Co. Limited20230—
+6K223440Plasma Pen (Plasma MD); Plasma Pen (Plasma +)Plasma Concepts20230—
+6K223222Plasma IQNeauvia North America, Inc.20233—
+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—
+6K191484Renuvion/J-Plasma Precise HandpieceApyx Medical Corporation (Formerly Bovie Medical Corporation)20190—
+7K251334New Doublo 2.0Hironic Co., Ltd.20250—
+7K241099Plasonic (Plasonic)Hironic Co., Ltd.20242—
+7K230272Renuvion® APR HandpieceApyx Medical Corporation20231—
+7K223262Renuvion® APR HandpieceApyx Medical Corporation20232—
+8K260397SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)Hironic Co., Ltd.20260—
+8K230586Renuvion® Micro HandpieceApyx Medical Corporation20230—