510(k) Report

Devices descending from K933157

144 later devices reach Erbotom Icc 200 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K123429Olympus Energy Power System (Eps)Gyrus Acmi, Inc.2013112
+6K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.20260—
+6K254220Reusable 3 Button Fingerswitch WandSoniquence, LLC20260—
+6K250852CoolfaseAsterasys Co., Ltd.20250—
+6K250483PhotonBlade 3; PhotonBlade 3 Smoke EvacuationStryker Instruments20250—
+6K251327XERFLutronic Corporation202501
+6K240857Youmagic FLM System (YM5-U1)We Medical Technology (Wuxi) Co., Ltd.20250—
+6K242241SunnyShenB Co., Ltd.20250—
+6K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+6K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+6K242688Finiff SystemSkingrab Co., Ltd.20240—
+6K242553MIRARI® Cold Plasma System ( GV-M2-01)General Vibronics, Inc.20240—
+6K240248Volnewmer™Classys, Inc.20241—
+6K23299210THERMATentech, Inc.20230—
+6K230663DensityJeisys Medical, Inc.20232—
+6K221989The OligioWontech Co., Ltd.20222—
+6K212222Soniquence Reusable 3 Button Fingerswitch WandSoniquence, LLC20221—
+6K212891TempSure SystemCynosure, LLC20221—
+6K211639BTL-785WBTL Industries, Inc.20227—
+6K220071Soniquence Reusable Neutral PlateSoniquence, LLC20220—
+6K212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc.20220—
+6K210129RF Thermal SystemLuvo Medical Technologies, Inc.20211—
+6K202562Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and Tips…Ellusa, LLC20201—
+6K200146HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery MonitorCovidien, LLC20200—
+6K191583PhotonBlade with Smoke EvacuationInvuity, Inc.20200—
+6K141484Open FmsealerDomain Surgical, Inc.201411
+6K140384Fmwand Handpiece SEDomain Surgical, Inc.20140—
+7K253504Volnewmer™Classys, Inc.20260—
+7K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+7K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+7K250065DENSITY; DENZA; DENSITY NoirJeisys Medical Incorporated20250—
+7K240897CellinewVIOL Co., Ltd.20240—
+7K240313Oligio XWontech Co., Ltd.20241—
+7K222556BTL-785XBTL Industries, Inc.20235—
+7K223292TempSure SystemCynosure, LLC20220—
+7K222425Ellusa Reusable Neutral PlatesEllusa, LLC20220—
+7K212607DarwinLuvo Medical Technologies, Inc.20210—
+7K142229Laparoscopic FMsealerDomain Surgical, Inc.20150—
+8K243929Oligio XWontech Co., Ltd.20250—
+8K233849BTL-499BTL Industries, Inc.20240—
+8K233604BTL-785SBTL Industries, Inc.20243—
+9K253750BTL-785NEHBTL Industries, Inc.20260—
+9K242532BTL-785BNF-EBTL Industries, Inc.20241—
+10K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—