510(k) Report

Devices descending from K013255

104 later devices reach Surgitron 120 Iec (Also Known as Surgitron 4.0 Dual RF through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200931RF Surgical GeneratorFulwell, LLC20200—
+1K123366Surgitron 4.0 Dual RF S5-IecEllman International, Inc.2013161
+1K082834Ellman International Non-Ablative Technique for Surgitron IecEllman Int'L, Inc.2009561
+1K073057Pulsar Generator, Model PS100-100, and Peak Plasmablade Tissue Dissection Device, Model…Peak Surgical, Inc.200833—
+1K061174Surgi-MaxEllman Int'L, Inc.200635—
+1K051956DR. Oppel ST-501Sometech Incorporated20051—
+2K182365TempSure SystemCynosure, Inc.201815—
+2K181257PlasmaBlade X 3.0S, PlasmaBlade X 4.0Medtronic Advanced Energy20183—
+2K134036Wavetronic 5000 Digital HF Surgical UnitLoktal Medical Electronics Ind. Com. Ltda- Epp20150—
+2K130689Symphony RF GeneratorThermigen, Inc.201311—
+2K122966XP200Btl Industries, Ltd.20131—
+2K102698Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model Pelleve GlidesafeEllman Int'L, Inc.201139—
+2K100390Surgimax/ Surgimax PlusElliquence, LLC201010—
+2K101967Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve'Ellman Int'L, Inc.201053—
+2K083352Veinwave, TC3000Newlands Clinical Trials, Ltd.20094—
+2K083415Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection DevicePeak Surgical, Inc.20098—
+2K082786Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection DevicesPeak Surgical, Inc.2008241
+3K240311JETT Medical IICompex, Spol, S.R.O.20250—
+3K210077MED RF 4000F Care Systems USA, LLC20211—
+3K193579PlasmaBlade X 3.0S LIGHTMedtronic Navigation20202—
+3K190678TempSureCynosure, Inc.201914—
+3K171869Sutter CURIS RF GeneratorSutter Medizintechnik GmbH20181—
+3K173582ThermiX Temperature Control Radiofrequency System, Accessories - RF ElectrodesThermigen, L.L.C20181—
+3K171094Thermi Reusable Non-invasive RF ElectrodeThermgen, L.L.C20176—
+3K170107Surgi Max UltraElliquence, LLC20177—
+3K161661Thermi RF AccessoriesThermi20163—
+3K152703PlasmaBlade TnA Tonsil and Adenoid Dissection DeviceMedtronic Advanced Energy20160—
+3K160041Cobbra RF Tissue DissectorElliquence, LLC20166—
+3K151793InMode RF SystemInmode MD, Ltd.20161—
+3K152702Ent Biotech Solutions Tissue Removal Device (Elasso)Ent Biotech Solutions20160—
+3K142410Elliquence ElectrodesElliquence, LLC20157—
+3K150297PlasmaBlade UPPP and Suction CoagulatorMedtronic Advanced Energy20150—
+3K143109XP300BTL Industries, Inc.20150—
+3K143175AEx Generator; PlasmaBlade TMedtronic Advanced Energy20141—
+3K132665Pelleve Glidesafe 10MM, 15MM & 20MM Handpiece, Pelleve S5 - IecEllman International, Inc.201317—
+3K132431Thermage CPT SystemSolta Medical, Inc.2013171
+3K130283Evrf SystemF Care Systems NV20132—
+3K121881Domain Surgical SystemDomain Surgical, Inc.20124—
+3K121678DTADGyrus Acmi, Inc.20122—
+3K112334Vein-Gogh InstrumentRefine USA, LLC20120—
+3K103775Peak Suction CoagulatorPeak Surgical, Inc.20111—
+3K102709Peak Plasmablade Plus Tissue Dissection DevicePeak Surgical, Inc.20100—
+3K102029Peak Pulsar II Generator Model PS100-102Peak Surgical, Inc.20100—
+3K102368Non-Ablative Wrinkle Treatment HandpieceEllman Int'L, Inc.201052—
+3K093695Peak Plasmablade 3.OS Tissue Dissection DevicePeak Surgical, Inc.20108—
+4K251813CURIS II RF Generator (REF 360100-05)Sutter Medizintechnik GmbH20260—
+4K252704F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St)F Care Systems USA, LLC20250—
+4K242266PhotonBlade 3; PhotonBlade 3 Smoke EvacuationStryker Instruments20241—
+4K222260Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500Capenergy Medical S.L.20233—
+4K222709Retraction, CWM-910T, APOLEX TiteChungwoo Co., Ltd.20230—
+4K200241TempSure SystemCynosure, LLC202013—
+4K183611Soniquence RF Generator and Soniquence ElectrodesSoniquence, LLC20195—
+4K173759Thermage CPT System and AccessoriesSolta Medical201821
+4K170054iSurgJaco, LLC Dba Macan Manufacturing and Bna Burz North America20170—
+4K170758Thermage FLX System and AccessoriesSolta Medical201713—
+4K171262TempSureCynosure, Inc.201716—
+4K170610PlasmaBlade TMedtronic Advanced Energy20170—
+4K170116Thermi Injectable RF ElectrodesThermi20172—
+4K163190InMode RF SystemInmode MD, Ltd.20160—
+4K162053PhotonBladeInvuity, Inc.201611
+4K130606Fmwand Ferromagnetic Surgical SystemDomain Surgical, Inc.20143—
+4K123429Olympus Energy Power System (Eps)Gyrus Acmi, Inc.2013112
+5K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.20260—
+5K254220Reusable 3 Button Fingerswitch WandSoniquence, LLC20260—
+5K250852CoolfaseAsterasys Co., Ltd.20250—
+5K250483PhotonBlade 3; PhotonBlade 3 Smoke EvacuationStryker Instruments20250—
+5K251327XERFLutronic Corporation202501
+5K240857Youmagic FLM System (YM5-U1)We Medical Technology (Wuxi) Co., Ltd.20250—
+5K242241SunnyShenB Co., Ltd.20250—
+5K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+5K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+5K242688Finiff SystemSkingrab Co., Ltd.20240—
+5K242553MIRARI® Cold Plasma System ( GV-M2-01)General Vibronics, Inc.20240—
+5K240248Volnewmer™Classys, Inc.20241—
+5K23299210THERMATentech, Inc.20230—
+5K230663DensityJeisys Medical, Inc.20232—
+5K221989The OligioWontech Co., Ltd.20222—
+5K212222Soniquence Reusable 3 Button Fingerswitch WandSoniquence, LLC20221—
+5K212891TempSure SystemCynosure, LLC20221—
+5K211639BTL-785WBTL Industries, Inc.20227—
+5K220071Soniquence Reusable Neutral PlateSoniquence, LLC20220—
+5K212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc.20220—
+5K210129RF Thermal SystemLuvo Medical Technologies, Inc.20211—
+5K202562Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and Tips…Ellusa, LLC20201—
+5K191583PhotonBlade with Smoke EvacuationInvuity, Inc.20200—
+5K141484Open FmsealerDomain Surgical, Inc.201411
+5K140384Fmwand Handpiece SEDomain Surgical, Inc.20140—
+6K253504Volnewmer™Classys, Inc.20260—
+6K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+6K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+6K250065DENSITY; DENZA; DENSITY NoirJeisys Medical Incorporated20250—
+6K240897CellinewVIOL Co., Ltd.20240—
+6K240313Oligio XWontech Co., Ltd.20241—
+6K222556BTL-785XBTL Industries, Inc.20235—
+6K223292TempSure SystemCynosure, LLC20220—
+6K222425Ellusa Reusable Neutral PlatesEllusa, LLC20220—
+6K212607DarwinLuvo Medical Technologies, Inc.20210—
+6K142229Laparoscopic FMsealerDomain Surgical, Inc.20150—
+7K243929Oligio XWontech Co., Ltd.20250—
+7K233849BTL-499BTL Industries, Inc.20240—