510(k) Report

Devices descending from K950239

1,329 later devices reach Sensimatic 500SE through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K030186Polris LVSyneron Medical, Ltd.2003680—
+6K024064Polaris DSSyneron Medical, Ltd.2003681—
+6K030142Thermacool TC SystemThermage, Inc.2003773—
+7K253918Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St)F Care Systems USA, LLC20260—
+7K261202ENTire IRE SystemEntire Medical, Ltd.20260—
+7K250688Cedar™ Endovenous Radiofrequency Catheter (ERA-C70-US); Cedar™ Endovenous Radiofrequency…Acotec Scientific Co., Ltd.20250—
+7K252316Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)Venclose, Inc.20250—
+7K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+7K250068Venclose digiRF Generator (VCRFG1)Venclose, Inc.202511
+7K240070Profound MatrixCandela Corporation20240—
+7K231749Radio Frequency SystemShenzhenshi Sincoheren S&T Development Co., Ltd.20230—
+7K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+7K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+7K222556BTL-785XBTL Industries, Inc.20235—
+7K222260Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500Capenergy Medical S.L.20233—
+7K223488ClosureFast™ Endovenous Radiofrequency Ablation CatheterMedtronic, Inc.20230—
+7K222709Retraction, CWM-910T, APOLEX TiteChungwoo Co., Ltd.20230—
+7K211639BTL-785WBTL Industries, Inc.20227—
+7K210077MED RF 4000F Care Systems USA, LLC20211—
+7K211217Profound MatrixCandela Corporation20210—
+7K202288FinebeamSNJ Co., Ltd.20212—
+7K211838Ultrasonic Bipolar Generator USG-410 with accessoriesOlympus Medical Systems Corporation2021313
+7K192621Medical RFTriworks Group Srl20200—
+7K193201BTL-785FBtl20208—
+7K200104OxylightRaja Trading Company, Inc.202024—
+7K192103Thunderbeat Open Fine Jaw Type X Hand InstrumentOlympus Medical Systems Corp.20204—
+7K191073Vein360 Endovenous Radiofrequency Ablation (RFA) CatheterVein 360, LLC20190—
+7K190610Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologySterilmed, Inc.20190—
+7K180359BTL-FR2000BTL Industries, Inc.20189—
+7K180945LUTRONIC GENIUS Radiofrequency SystemLutronic Corporation20181—
+7K180872Scarlet SRFVIOL Co., Ltd.20184—
+7K181510Echolaser X4El.En Electronic Engineering Spa20183—
+7K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+7K180584Viveve RF System, SecureViveve, Inc.20185—
+7K173759Thermage CPT System and AccessoriesSolta Medical201821
+7K172023CelfirmVIOL Co., Ltd.20173—
+7K170758Thermage FLX System and AccessoriesSolta Medical201713—
+7K170908PK AIMGyrus Acmi, Inc.20170—
+7K170456Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologyStryker Sustainability Solutions201701
+7K170116Thermi Injectable RF ElectrodesThermi20172—
+7K161949OsteoCool V-3 RF Ablation SystemBaylis Medical Company, Inc.20177—
+7K162851eLyx-PROIntelligent Sensory Concept SA20170—
+7K163190InMode RF SystemInmode MD, Ltd.20160—
+7K160312Fraxis DuoIlooda Co,., Ltd.201614—
+7K161825PK AIMGyrus Acmi, Inc.20162—
+7K153727INTRAcel Premium Fractional RF Micro Needle (FRM) SystemJeisys Medical, Inc.201627—
+7K153371Sonicision Cordless Ultrasonic Dissection DeviceCovidien, LLC20164—
+7K150409VIVACE Electrosurgical SystemSung Hwan E&B Co.,Ltd201681
+7K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+7K150524Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue TechnologySurgical Instrument Services and Savings, Inc.20150—
+7K151340HARMONIC Focus Long Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC20150—
+7K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+7K150336Photonica ProfessionalWard Photonics, LLC20157—
+7K142759PK Cutting Forceps for ESG-400 WorkstationGyrus Acmi, Inc.20152—
+7K133405MinnieElettronica Valseriana Srl20140—
+7K134017GigalaserPowermedic Aps20141—
+7K132286Hyperion Long Pulsed ND: Yag LaserScarlet Rf, Inc.20143—
+7K131142Genesis Led WandsGenesis Biosystems, Inc.20130—
+7K132431Thermage CPT SystemSolta Medical, Inc.2013171
+7K122966XP200Btl Industries, Ltd.20131—
+7K130283Evrf SystemF Care Systems NV20132—
+7K121508Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-NFotona D.D.20121—
+7K120460SmartluxMedmix Co., Ltd.201218—
+7K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+7K120235Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo…Aerolase Medical Lasers, LLC201233—
+7K120527Alpha Orthopaedics AT2 SystemAlpha Orthopaedics, Inc.20120—
+7K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+7K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+7K112334Vein-Gogh InstrumentRefine USA, LLC20120—
+7K110375Blueshine's Gold SeriesBlueshine Srl20124—
+7K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+7K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+7K111887Closurefast Radiofrequency CatheterCovidien20116—
+7K101306SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models…Fotona D.D.201178—
+7K101916Joule Multi-Platform SystemSciton, Inc2011111—
+7K101147Modified Alma Lasers Family of Accent Radiofrequency (RF) SystemAlma Lasers, Inc.20114—
+7K100586Venus Freeze SystemVenus Concept, Ltd.201031—
+7K102003Xpress Balloon DeviceEntellus Medical, Inc.201036—
+7K092734E-Light LineEspansione Marketing S.P.A20102—
+7K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+7K101967Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve'Ellman Int'L, Inc.201053—
+7K100558Quanta Diode Laser SystemQuanta System Spa201068—
+7K090661Nes Reprocessed Varicose Vein RF CatheterNortheast Scientific, Inc.20100—
+7K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+7K093007Entellus Medical Balloon DeviceEntellus Medical, Inc.201041—
+7K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+7K093855Halo 360 & Sizing Balloon, Model 3441CBarrx Medical, Incorporated20103—
+7K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+7K082586Lightwave Professional DeluxeLightwave Technologies, LLC20104—
+7K090762LEDAQuantel Derma GmbH200946—
+7K083461Imagine TC Skin Therapy SystemEndymion Medical, Ltd.2009101—
+7K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+7K091323Modified Intermedic Diode Laser 980NM System (Multidiode SST 200)Intermedic Arfran, SA20090—
+7K082834Ellman International Non-Ablative Technique for Surgitron IecEllman Int'L, Inc.2009561
+7K083737Halo Ablation CatheterBarrx Medical, Incorporated200922—
+7K083711Modification to: Halo Coagulation Catheter, Models 32041-18, 32041-20, 32041-22…Barrx Medical, Incorporated200917—
+7K081307Omnilux Clear-UPhoto Therapeutics, Inc.2009169—
+7K082622Alma Lasers Accent B-Shape Massager Handpiece/ModuleAlma Lasers, Ltd.200945—
+7K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+7K082445CURATIVE980 Diode LaserOroscience, Inc.20080—