510(k) Report

Devices descending from K921884

1,365 later devices reach FORCE 2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K121507Atricure Cryo Module System (Acm, CRYO1, and Cryoice)AtriCure, Inc.201211—
+6K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+6K112334Vein-Gogh InstrumentRefine USA, LLC20120—
+6K101916Joule Multi-Platform SystemSciton, Inc2011111—
+6K101147Modified Alma Lasers Family of Accent Radiofrequency (RF) SystemAlma Lasers, Inc.20114—
+6K100586Venus Freeze SystemVenus Concept, Ltd.201031—
+6K102003Xpress Balloon DeviceEntellus Medical, Inc.201036—
+6K092734E-Light LineEspansione Marketing S.P.A20102—
+6K101967Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve'Ellman Int'L, Inc.201053—
+6K093007Entellus Medical Balloon DeviceEntellus Medical, Inc.201041—
+6K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+6K082586Lightwave Professional DeluxeLightwave Technologies, LLC20104—
+6K090762LEDAQuantel Derma GmbH200946—
+6K083461Imagine TC Skin Therapy SystemEndymion Medical, Ltd.2009101—
+6K082834Ellman International Non-Ablative Technique for Surgitron IecEllman Int'L, Inc.2009561
+6K081307Omnilux Clear-UPhoto Therapeutics, Inc.2009169—
+6K082622Alma Lasers Accent B-Shape Massager Handpiece/ModuleAlma Lasers, Ltd.200945—
+6K082247Evis MD Platinum Red Light TherapyAgeless Beauty Corporation20081—
+6K073000LumaprobeClareblend, Inc.20080—
+6K073022Clareblend Led Probes Model# 7201-415, 7204-631, 7205-830Clareblend, Inc.20080—
+6K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+6K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+6K072459Omnilux New-UPhoto Therapeutics, Inc.200891—
+6K072699Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent, Accent XLAlma Lasers, Ltd.200784—
+6K072152Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc.200734—
+6K071786Portrait PSRRhytec Incorporated2007109—
+6K070388Profile Multi-Platform SystemSciton, Inc2007129—
+6K060792IllumimedPhotoactif, LLC2006115—
+6K063538Arthrocare Controller (System 2000 and 8000), Arthrocare Patient Cable, Foot Control…Arthrocare Corp.200640—
+6K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA2006299—
+6K060448Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd.2006297—
+6K061117Nanolite Skin Care SystemNanolite Technology, Inc.20060—
+6K052778Thermage Thermacool Skin MarketingThermage, Inc.2005130—
+6K051259Versaclear Skin Therapy System, Model 100Theralight, Inc.200547—
+6K050216Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited2005160—
+6K051255Lumiphase-ROpusmed, Inc.2005143—
+6K050397Velasmooth, ShaperSyneron Medical, Ltd.2005150—
+6K050452Aurora SR and Sra ApplicatorSyneron Medical, Ltd.2005301—
+6K043575Dermillume, Model PRO1000Care Electronics, Inc.20054—
+6K041959Polaris DS/CometSyneron Medical, Ltd.2004301—
+6K032514AC Applicator, Aurora ACSyneron Medical, Ltd.20041—
+6K033586Modification to Aurora DSSyneron Medical, Ltd.2003303—
+6K031671Polaris WRSyneron Medical, Ltd.2003678—
+6K030186Polris LVSyneron Medical, Ltd.2003680—
+7K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.20260—
+7K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.20260—
+7K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…Olympus Medical Systems Corp.20260—
+7K253484Lutronic GeniusCynosure Lutronic Technology Corporation20260—
+7K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+7K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+7K252704F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St)F Care Systems USA, LLC20250—
+7K250852CoolfaseAsterasys Co., Ltd.20250—
+7K252150Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410)…Olympus Medical Systems Corporation202504
+7K252316Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)Venclose, Inc.20250—
+7K251327XERFLutronic Corporation202501
+7K240857Youmagic FLM System (YM5-U1)We Medical Technology (Wuxi) Co., Ltd.20250—
+7K250371cryoICE cryoXT cryoablation probe (cryoXT)AtriCure, Inc.20250—
+7K242241SunnyShenB Co., Ltd.20250—
+7K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+7K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+7K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+7K242688Finiff SystemSkingrab Co., Ltd.20240—
+7K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+7K240248Volnewmer™Classys, Inc.20241—
+7K233849BTL-499BTL Industries, Inc.20240—
+7K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+7K233604BTL-785SBTL Industries, Inc.20243—
+7K233024Alma HarmonyAlma Lasers, Inc.20241—
+7K23299210THERMATentech, Inc.20230—
+7K233170cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe…AtriCure, Inc.20230—
+7K231777Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories…Olympus Winter & Ibe GmbH202302
+7K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+7K230663DensityJeisys Medical, Inc.20232—
+7K230308Alma HarmonyAlma Lasers, Inc.20232—
+7K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+7K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+7K221989The OligioWontech Co., Ltd.20222—
+7K213761Joule diVa SystemSciton, Inc20220—
+7K221571InMode Multi-systemInMode, Ltd.20222—
+7K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+7K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+7K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+7K203277Electrosurgical Generator ESG-410, Foot Switches, PK Cutting ForcepsOlympus Winter & Ibe GmbH202114
+7K193070VIVACE Electrosurgical DeviceShenB Co., Ltd.20214—
+7K203054FlexSysGme German Medical Engineering GmbH20210—
+7K202415VirtueRFShenB Co., Ltd.20213—
+7K202361UltraSlim Digital, UltraSmooth DigitalWard Photonics, LLC20200—
+7K192406AveCure BT Microwave Ablation SystemMedwaves, Inc.20200—
+7K200472Viveve SystemViveve Medical, Inc.20202—
+7K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+7K200427Sonicision Cordless Ultrasonic DissectorCovidien, LLC20200—
+7K192856MT OneM&T S.R.L.20202—
+7K200185Sylfirm XVIOL Co., Ltd.20202—
+7K193656SkyPulseFotona D.O.O.202011—
+7K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+7K192545PotenzaJeisys Medical Incorporated202020—
+7K183284INTRAcel RF Microneedle SystemJeisys Medical, Inc.20200—
+7K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+7K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+7K193162EPi-Sense Guided Coagulation System with VisiTraxAtriCure, Inc.20190—