510(k) Report

Devices descending from K984552

1,174 later devices reach Cool-Tip RF System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K231738NEUWAVE™ Microwave Ablation System and AccessoriesNeuwave Medical, Inc.20230—
+4K231749Radio Frequency SystemShenzhenshi Sincoheren S&T Development Co., Ltd.20230—
+4K223303Spinery™ RF Ablation SystemAxon Spine Medical System20230—
+4K222556BTL-785XBTL Industries, Inc.20235—
+4K222260Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500Capenergy Medical S.L.20233—
+4K222709Retraction, CWM-910T, APOLEX TiteChungwoo Co., Ltd.20230—
+4K221074OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion DeviceStryker Corporation20222—
+4K211639BTL-785WBTL Industries, Inc.20227—
+4K210077MED RF 4000F Care Systems USA, LLC20211—
+4K211217Profound MatrixCandela Corporation20210—
+4K192406AveCure BT Microwave Ablation SystemMedwaves, Inc.20200—
+4K192621Medical RFTriworks Group Srl20200—
+4K193201BTL-785FBtl20208—
+4K200104OxylightRaja Trading Company, Inc.202024—
+4K182605HS AMICA devices familyH.S Hospital Service S.P.A20191—
+4K180359BTL-FR2000BTL Industries, Inc.20189—
+4K180945LUTRONIC GENIUS Radiofrequency SystemLutronic Corporation20181—
+4K173756Certus 140 2.45GHz Ablation SystemNeuwave Medical, Inc.20183—
+4K180872Scarlet SRFVIOL Co., Ltd.20184—
+4K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+4K180584Viveve RF System, SecureViveve, Inc.20185—
+4K173759Thermage CPT System and AccessoriesSolta Medical201821
+4K172023CelfirmVIOL Co., Ltd.20173—
+4K170758Thermage FLX System and AccessoriesSolta Medical201713—
+4K170116Thermi Injectable RF ElectrodesThermi20172—
+4K162851eLyx-PROIntelligent Sensory Concept SA20170—
+4K163190InMode RF SystemInmode MD, Ltd.20160—
+4K160312Fraxis DuoIlooda Co,., Ltd.201614—
+4K153727INTRAcel Premium Fractional RF Micro Needle (FRM) SystemJeisys Medical, Inc.201627—
+4K150409VIVACE Electrosurgical SystemSung Hwan E&B Co.,Ltd201681
+4K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+4K150089NanoKnife SystemAngioDynamics, Inc.201581
+4K141785Micro Thermx Microwave Ablation System and AccessoriesBsd Medical Corp.20150—
+4K150336Photonica ProfessionalWard Photonics, LLC20157—
+4K141511SIDELAZE800 Laser Beam Delivery Accessory for Cynosure 1440MM Wavelength LasersCynosure, Inc.20150—
+4K133405MinnieElettronica Valseriana Srl20140—
+4K134017GigalaserPowermedic Aps20141—
+4K133821Emprint Ablation SystemCovidien, LLC2014297
+4K131142Genesis Led WandsGenesis Biosystems, Inc.20130—
+4K131162Miradry SystemMiramar Labs, Inc.201331
+4K132431Thermage CPT SystemSolta Medical, Inc.2013171
+4K122966XP200Btl Industries, Ltd.20131—
+4K130283Evrf SystemF Care Systems NV20132—
+4K120460SmartluxMedmix Co., Ltd.201218—
+4K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+4K120527Alpha Orthopaedics AT2 SystemAlpha Orthopaedics, Inc.20120—
+4K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+4K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+4K112334Vein-Gogh InstrumentRefine USA, LLC20120—
+4K101916Joule Multi-Platform SystemSciton, Inc2011111—
+4K101147Modified Alma Lasers Family of Accent Radiofrequency (RF) SystemAlma Lasers, Inc.20114—
+4K100586Venus Freeze SystemVenus Concept, Ltd.201031—
+4K092734E-Light LineEspansione Marketing S.P.A20102—
+4K101967Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve'Ellman Int'L, Inc.201053—
+4K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+4K082586Lightwave Professional DeluxeLightwave Technologies, LLC20104—
+4K090762LEDAQuantel Derma GmbH200946—
+4K083461Imagine TC Skin Therapy SystemEndymion Medical, Ltd.2009101—
+4K082834Ellman International Non-Ablative Technique for Surgitron IecEllman Int'L, Inc.2009561
+4K081307Omnilux Clear-UPhoto Therapeutics, Inc.2009169—
+4K082622Alma Lasers Accent B-Shape Massager Handpiece/ModuleAlma Lasers, Ltd.200945—
+4K082247Evis MD Platinum Red Light TherapyAgeless Beauty Corporation20081—
+4K073000LumaprobeClareblend, Inc.20080—
+4K073022Clareblend Led Probes Model# 7201-415, 7204-631, 7205-830Clareblend, Inc.20080—
+4K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+4K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+4K072459Omnilux New-UPhoto Therapeutics, Inc.200891—
+4K072699Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent, Accent XLAlma Lasers, Ltd.200784—
+4K072152Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc.200734—
+4K071786Portrait PSRRhytec Incorporated2007109—
+4K070388Profile Multi-Platform SystemSciton, Inc2007129—
+4K060792IllumimedPhotoactif, LLC2006115—
+4K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA2006299—
+4K060448Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd.2006297—
+4K061117Nanolite Skin Care SystemNanolite Technology, Inc.20060—
+4K052778Thermage Thermacool Skin MarketingThermage, Inc.2005130—
+4K051259Versaclear Skin Therapy System, Model 100Theralight, Inc.200547—
+4K050216Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited2005160—
+4K051255Lumiphase-ROpusmed, Inc.2005143—
+4K050397Velasmooth, ShaperSyneron Medical, Ltd.2005150—
+4K050452Aurora SR and Sra ApplicatorSyneron Medical, Ltd.2005301—
+4K043575Dermillume, Model PRO1000Care Electronics, Inc.20054—
+4K041959Polaris DS/CometSyneron Medical, Ltd.2004301—
+4K032514AC Applicator, Aurora ACSyneron Medical, Ltd.20041—
+4K033586Modification to Aurora DSSyneron Medical, Ltd.2003303—
+4K031671Polaris WRSyneron Medical, Ltd.2003678—
+4K030186Polris LVSyneron Medical, Ltd.2003680—
+5K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.20260—
+5K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.20260—
+5K253484Lutronic GeniusCynosure Lutronic Technology Corporation20260—
+5K253656OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K252833VIVA combo RF SystemStarmed Co., Ltd.20260—
+5K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+5K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+5K252704F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St)F Care Systems USA, LLC20250—
+5K250852CoolfaseAsterasys Co., Ltd.20250—
+5K251327XERFLutronic Corporation202501
+5K240857Youmagic FLM System (YM5-U1)We Medical Technology (Wuxi) Co., Ltd.20250—
+5K250327OptaBlate Radiofrequency (RF) Generator SystemStryker Instruments20250—
+5K242241SunnyShenB Co., Ltd.20250—