510(k) Report

Devices descending from K981870

1,073 later devices reach Visage Cosmetic Surgery System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072261Finesse SystemPrimaeva Medical, Inc.2007100—
+1K012631Reprocessed Soft Tissue AblatorsAlliance Medical Corp.20011—
+1K000944Thermage Thermacool SystemThermage, Inc.20001,069—
+1K992180Visage Cosmetic Surgery, Model V5000Arthrocare Corp.20003—
+2K130689Symphony RF GeneratorThermigen, Inc.201311—
+2K082391Primaeva Medical Renesis SystemPrimaeva Medical, Inc.200959—
+2K082962Tivamed Cooled RF System, Model 78001Tivamed, Inc.20087—
+2K080145Primaeva Medical SystemPrimaeva Medical, Inc.200899—
+2K052692Suretek Medical Reprocessed Electrosurgical ElectrodesSuretek Medical20060—
+2K043402Thermage Thermacool SystemThermage, Inc.2005124—
+2K033942Thermage Thermacool SystemThermage, Inc.2004527—
+2K023111Gyrus Plasma Skin Resurfacing SystemGyrus Medical, Inc.20030—
+2K021402Thermage Thermacool TC SystemThermage, Inc.2002789—
+2K022266Aurora SRSyneron Medical, Ltd.2002705—
+2K021149Aurora DSSyneron Medical, Ltd.2002750—
+2K013639Thermage Thermacool TC SystemThermage, Inc.2002799—
+2K013034Modification to: Thermacool IiaThermage, Inc.2001800—
+3K173582ThermiX Temperature Control Radiofrequency System, Accessories - RF ElectrodesThermigen, L.L.C20181—
+3K171094Thermi Reusable Non-invasive RF ElectrodeThermgen, L.L.C20176—
+3K162547Viveve SystemViveve, Inc.20166—
+3K161043Profound SystemSyneron Candela Corporation20160—
+3K161661Thermi RF AccessoriesThermi20163—
+3K151793InMode RF SystemInmode MD, Ltd.20161—
+3K130501IntensifEndymed Medical, Ltd.201457—
+3K121481Infini Radiofrequency SystemLutronic Corporation201357—
+3K094041Alpha Orthopaedics AT3 SystemAlpha Orthopaedics20100—
+3K092191Exilis, Model 5000Btl Industries, Ltd.200912—
+3K090580Thermage Thermacool NXT System and AccessoriesSolta Medical, Inc.200919—
+3K083352Veinwave, TC3000Newlands Clinical Trials, Ltd.20094—
+3K083590Iskra Medical Green Irf PrestigeIskra Medical, D.O.O.200913—
+3K082956Alpha Orthopaedics AT2 SystemAlpha Orthopaedics20081—
+3K072849Modification to Thermage Thermacool SystemThermage, Inc.200820—
+3K052936Thermage Thermacool SystemThermage, Inc.2007103—
+3K070004AccentAlma Lasers, Ltd.2007181—
+3K060948Portrait PSR3Rhytec Incorporated20061101
+3K051214Aluma Skin Renewal SystemLumenis, Inc.2005476—
+3K051710Thermage Thermacool Coupling FluidThermage, Inc.200556—
+3K042630Revlight Skin Care SystemSkincare Technology, Inc.2005402—
+3K043329Omnilux Revive and BluePhoto Therapeutics Limited2005202—
+3K040135Thermage Thermacool SystemThermage, Inc.2004496—
+3K031489PitangaSyneron Medical, Ltd.20030—
+3K032088Modification to Thermacool TC SystemThermage, Inc.2003131—
+3K031988Aurora DSSyneron Medical, Ltd.2003450—
+3K031993Aurora SRSyneron Medical, Ltd.2003303—
+3K030426Omnilux RedPhoto Therapeutics Limited2003563—
+3K031046Thermacool TC SystemThermage, Inc.200322—
+3K024064Polaris DSSyneron Medical, Ltd.2003681—
+3K030142Thermacool TC SystemThermage, Inc.2003773—
+4K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+4K240070Profound MatrixCandela Corporation20240—
+4K231749Radio Frequency SystemShenzhenshi Sincoheren S&T Development Co., Ltd.20230—
+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—
+4K211639BTL-785WBTL Industries, Inc.20227—
+4K210077MED RF 4000F Care Systems USA, LLC20211—
+4K211217Profound MatrixCandela Corporation20210—
+4K192621Medical RFTriworks Group Srl20200—
+4K193201BTL-785FBtl20208—
+4K200104OxylightRaja Trading Company, Inc.202024—
+4K180359BTL-FR2000BTL Industries, Inc.20189—
+4K180945LUTRONIC GENIUS Radiofrequency SystemLutronic Corporation20181—
+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—
+4K150336Photonica ProfessionalWard Photonics, LLC20157—
+4K133405MinnieElettronica Valseriana Srl20140—
+4K134017GigalaserPowermedic Aps20141—
+4K131142Genesis Led WandsGenesis Biosystems, Inc.20130—
+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—