510(k) Report

Devices descending from K981870

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+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—
+5K242241SunnyShenB Co., Ltd.20250—
+5K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) 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—
+5K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+5K240248Volnewmer™Classys, Inc.20241—
+5K233849BTL-499BTL Industries, Inc.20240—
+5K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+5K233604BTL-785SBTL Industries, Inc.20243—
+5K233024Alma HarmonyAlma Lasers, Inc.20241—
+5K23299210THERMATentech, Inc.20230—
+5K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+5K230663DensityJeisys Medical, Inc.20232—
+5K230308Alma HarmonyAlma Lasers, Inc.20232—
+5K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+5K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+5K221989The OligioWontech Co., Ltd.20222—
+5K213761Joule diVa SystemSciton, Inc20220—
+5K221571InMode Multi-systemInMode, Ltd.20222—
+5K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+5K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+5K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+5K193070VIVACE Electrosurgical DeviceShenB Co., Ltd.20214—
+5K203054FlexSysGme German Medical Engineering GmbH20210—
+5K202415VirtueRFShenB Co., Ltd.20213—
+5K202361UltraSlim Digital, UltraSmooth DigitalWard Photonics, LLC20200—
+5K200472Viveve SystemViveve Medical, Inc.20202—
+5K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+5K192856MT OneM&T S.R.L.20202—
+5K200185Sylfirm XVIOL Co., Ltd.20202—
+5K193656SkyPulseFotona D.O.O.202011—
+5K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+5K192545PotenzaJeisys Medical Incorporated202020—
+5K183284INTRAcel RF Microneedle SystemJeisys Medical, Inc.20200—
+5K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+5K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+5K191693BC-5Reveallux, Corp20190—
+5K183708Poly ClearMedtek Skincare, LLC201922—
+5K190938Phototherapy SystemShanghai Apolo Medical Technology Co., Ltd.201916—
+5K190422Viveve System 2.0Viveve Medical20194—
+5K180900LED Light Therapy DeviceUvbiotek, LLC201829—
+5K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+5K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+5K173285Joule SystemSciton, Inc20185—
+5K172096FraxisIlooda Co,., Ltd.20172—
+5K171055Philips BlueControlPhilips Electronics Nederland B.V.20171—
+5K170325Secret RFIlooda Co,., Ltd.201710—
+5K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+5K160469AGNESGowoonsesang Cosmetics Co., Ltd.20179—
+5K161941Pulsaderm Acne DeviceNutra Luxe MD, LLC20164—
+5K160880Photonica ProfessionalWard Photonics, LLC20166—
+5K160075Accent XLAlma Lasers, Inc.20160—
+5K153229SuperbiumBios S.R.L.20162—
+5K153081Clear Bi-LightMichael Todd, LP201646—
+5K134036Wavetronic 5000 Digital HF Surgical UnitLoktal Medical Electronics Ind. Com. Ltda- Epp20150—
+5K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+5K140386Lumina 24Rogers Sciences, Inc.20150—
+5K141237Harmony LiteAlma, Inc.20154—
+5K143109XP300BTL Industries, Inc.20150—
+5K142860Lumenis M22 SystemLumenis, Ltd.2015381
+5K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+5K142256Applied BioPhotonics Phototherapy System ABPT1003Applied Biophotonics, Ltd.20150—
+5K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+5K140926Inmode Wmface DeviceInmode MD, Ltd.20143—