510(k) Report

Devices descending from K030186

680 later devices reach Polris LV through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+5K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+5K242688Finiff SystemSkingrab Co., Ltd.20240—
+5K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+5K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+5K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+5K240248Volnewmer™Classys, Inc.20241—
+5K233849BTL-499BTL Industries, Inc.20240—
+5K233604BTL-785SBTL Industries, Inc.20243—
+5K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+5K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+5K23299210THERMATentech, Inc.20230—
+5K231146AliTightAlic Iotech, LLC20230—
+5K230663DensityJeisys Medical, Inc.20232—
+5K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+5K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+5K221865BTL-094BTL Industries, Inc.20230—
+5K223680Eneka ProTermosalud20230—
+5K210166Omnispec ED1000Medispec, Ltd.20230—
+5K222701MANTA LaserSqualus Med, Ltd.20222—
+5K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+5K221989The OligioWontech Co., Ltd.20222—
+5K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+5K222369PURE LaserEndymed Medical, Ltd.20220—
+5K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+5K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+5K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+5K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+5K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+5K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+5K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+5K193266MIINMedico USA, Inc.20210—
+5K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+5K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+5K201406PicowonWontech Co., Ltd.20200—
+5K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+5K200736Stardust MedI.T.S. Group S.R.L.20200—
+5K200104OxylightRaja Trading Company, Inc.202024—
+5K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+5K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+5K191065Venus VivaTMVenus Concept USA, Inc.20200—
+5K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+5K192545PotenzaJeisys Medical Incorporated202020—
+5K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+5K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+5K191528Venus Legacy Pro DeviceVenus Concept USA, Inc.20193—
+5K182774STOP U (Packed Black USA), STOP U (Packed White USA)Pollogen, Ltd.20195—
+5K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+5K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+5K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+5K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+5K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+5K173503Pollogen Legend SystemPollogen, Ltd.20183—
+5K173199PicoSure WorkstationCynosure, Inc.20189—
+5K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+5K171227StarWalkerFotona D.O.O.20177—
+5K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+5K172096FraxisIlooda Co,., Ltd.20172—
+5K170325Secret RFIlooda Co,., Ltd.201710—
+5K162755PicocareWontech Co., Ltd.20179—
+5K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+5K163415SlimShape SystemSyneron Medical, Ltd.201714—
+5K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+5K162512truSculptCutera, Inc.20165—
+5K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+5K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+5K152856Helios IIILaseroptek Co., Ltd.20165—
+5K160480PicoSure WorkstationCynosure, Inc.201620—
+5K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+5K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+5K153566Magma SystemFormatk Systems, Ltd.20162—
+5K153717Venus Versa SystemVenus Concept, Ltd.20161—
+5K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+5K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+5K152611V20 systemViora, Ltd.20164—
+5K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+5K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+5K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+5K151629Guardian 1000Quanta System Spa20150—
+5K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+5K143559XP1000 RFBTL Industries, Inc.20157—
+5K150035V10 systemViora, Ltd.201531—
+5K150326PicoWay Laser SystemCandela Corporation201568—
+5K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+5K143109XP300BTL Industries, Inc.20150—
+5K143105Picosure WorkstationCynosure, Inc.201549—
+5K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+5K142372Pico Way Laser SystemCandela Corpation201470—
+5K140120EPIC 10Biolase, Inc.20141—
+5K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S201461
+5K140719Picosure WorkstationCynosure, Inc.201450—
+5K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+5K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+5K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+5K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+5K130689Symphony RF GeneratorThermigen, Inc.201311—
+5K132665Pelleve Glidesafe 10MM, 15MM & 20MM Handpiece, Pelleve S5 - IecEllman International, Inc.201317—
+5K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+5K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+5K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—