510(k) Report

Devices descending from K961748

1,230 later devices reach Medlite/Erbium Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K231910DermRays ReviveWuhan Lotuxs Technology Co., Ltd.20240—
+7K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+7K232236EchoQuanta System Spa20230—
+7K231894LED Spectrum therapy instrumentShenzhenshi Sincoheren S&T Development Co., Ltd.20230—
+7K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+7K231394Intense Pulsed Light SystemSmedtrum Medical Technology Co., Ltd.20232—
+7K223033Tixel® 2 SystemNovoxel, Ltd.20230—
+7K230990Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)Candela Corporation20230—
+7K223566ELITA™ Femtosecond Laser System, ELITA™ Patient InterfaceJohnson & Johnson Surgical Vision, Inc.20230—
+7K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+7K223680Eneka ProTermosalud20230—
+7K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+7K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+7K222701MANTA LaserSqualus Med, Ltd.20222—
+7K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+7K213294Dermal Cooling SystemR2 Technologies, Inc.20221—
+7K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+7K222369PURE LaserEndymed Medical, Ltd.20220—
+7K213674CellFX SystemPulse Biosciences, Inc.20220—
+7K222075CellFX SystemPulse Biosciences, Inc.20220—
+7K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+7K221671CellFX® SystemPulse Biosciences, Inc.20220—
+7K211979Lumenis Y&R Laser SystemLumenis, Inc.20220—
+7K213261EpilMENeauvia North America20220—
+7K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+7K213039Micro-current facial cold and hot service (model: TPML-100)Li-Tek Electronics Technology C0., Ltd.20224—
+7K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+7K211639BTL-785WBTL Industries, Inc.20227—
+7K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+7K212771LightStim ElipsaLed Intellectual Properties, LLC20221—
+7K212107ReversoIntelis Instruments, Ltd.20211—
+7K203214DemarkQ WOW, DemarkQ POPShenzhen Kaiyan Medical CO, Ltd.202121—
+7K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+7K210535UltraLight LED SystemRohrer Aesthetics, LLC20210—
+7K202955Contour Light CL-100Contour Research, LLC20218—
+7K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+7K193266MIINMedico USA, Inc.20210—
+7K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+7K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+7K192275invisa-RED ELITEIR Technology, LLC20201—
+7K201406PicowonWontech Co., Ltd.20200—
+7K200736Stardust MedI.T.S. Group S.R.L.20200—
+7K200786Venus EpileveVenus Concept USA, Inc.20200—
+7K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+7K200751Photodynamic Therapy (PDT) EquipmentShangdong Huamei Technology Co., Ltd.20201—
+7K200659Dermalux Tri-Wave MDAesthetic Technology, Ltd.20203—
+7K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+7K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+7K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+7K192545PotenzaJeisys Medical Incorporated202020—
+7K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+7K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+7K192755Soli-Lite LG4 GalileoSilhouet-Tone Corporation20193—
+7K192521Intense Pulsed Light Treatment SystemShangdong Huamei Technology Co., Ltd.20193—
+7K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+7K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+7K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc.20190—
+7K182795LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc.20181—
+7K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+7K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+7K181868SHINY RPL SystemIds, Ltd.20181—
+7K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+7K180338CellulizeWard Photonics, LLC20182—
+7K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+7K181659Avologi ENEOPremier North America, Inc.20184—
+7K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+7K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+7K173503Pollogen Legend SystemPollogen, Ltd.20183—
+7K180593Vbeam Prima Laser SystemSyneron-Candela20182—
+7K180447reVive Light Therapy LED Cleansing SystemLed Technologies, Inc.201835—
+7K172555Sapphire, Elevare SapphireOmm Imports, Inc. D/B/A Zero Gravity201852—
+7K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+7K173371VisuMax Femtosecond LaserCarl Zeiss Meditec, Inc.20180—
+7K180320dpl IIa PanelLed Technologies, Inc.201814—
+7K173660LenSx Laser SystemAlcon Laboratories, Inc.20182—
+7K180406Ellipse YdunEllipse A/S20180—
+7K173346LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc.20183—
+7K173199PicoSure WorkstationCynosure, Inc.20189—
+7K172819LightWalker Laser System FamilyFotona D.O.O.201720—
+7K172111Vevazz LEDVevazz, LLC20170—
+7K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+7K162652Smart Photon Micro-current Device, Model: EP-300Li-Tek Electronic Technology Corporation201710—
+7K171014VICTUS Femtosecond Laser PlatformTechnolas Perfect Vision GmbH20171—
+7K171702Exciplex308nmClarteis20175—
+7K161434Photon Vibrating massage Facial Aesthetic Device (Model: UI-200)Li-Tek Electronics Technologies20173—
+7K172096FraxisIlooda Co,., Ltd.20172—
+7K170187Photodynamic Therapy DeviceUvbiotek, LLC20170—
+7K163137NIRA Beauty Skin LaserDermal Photonics Corporation20171—
+7K170850Alma QAlma Lasers, Ltd.20172—
+7K170325Secret RFIlooda Co,., Ltd.201710—
+7K162755PicocareWontech Co., Ltd.20179—
+7K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+7K170111Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37Pulsaderm, LLC201745—
+7K170576LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc.20171—
+7K170260BC-001+ Acne PurifierOriental Inspiration Limited20172—
+7K162784Silk'n HSTHome Skinovations, Ltd.20171—
+7K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+7K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+7K162098LED Phototherapy DeviceLi-Tek Electronic Technology Corporation201775—
+7K162781Magma SparkFormatk Systems, Ltd.20160—