510(k) Report

Devices descending from K954013

1,233 later devices reach Trilase 2940 Erbium Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+8K243139Reverso Pro SystemIndiba S. A. U.20250—
+8K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+8K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+8K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+8K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd.20246—
+8K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+8K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+8K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+8K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+8K233344Regenalase Laser SystemIpg Medical20240—
+8K240752Deka ToroEl.En S.P.A.20240—
+8K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+8K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+8K233416Cryojet Plus (SHE-ACP001-1)Beijing Sano Laser S&T Development Co.,Ltd20241—
+8K231910DermRays ReviveWuhan Lotuxs Technology Co., Ltd.20240—
+8K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+8K232236EchoQuanta System Spa20230—
+8K231894LED Spectrum therapy instrumentShenzhenshi Sincoheren S&T Development Co., Ltd.20230—
+8K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+8K231394Intense Pulsed Light SystemSmedtrum Medical Technology Co., Ltd.20232—
+8K223033Tixel® 2 SystemNovoxel, Ltd.20230—
+8K230990Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)Candela Corporation20230—
+8K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+8K223680Eneka ProTermosalud20230—
+8K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+8K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+8K222701MANTA LaserSqualus Med, Ltd.20222—
+8K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+8K213294Dermal Cooling SystemR2 Technologies, Inc.20221—
+8K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+8K222369PURE LaserEndymed Medical, Ltd.20220—
+8K213674CellFX SystemPulse Biosciences, Inc.20220—
+8K222075CellFX SystemPulse Biosciences, Inc.20220—
+8K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+8K221671CellFX® SystemPulse Biosciences, Inc.20220—
+8K211979Lumenis Y&R Laser SystemLumenis, Inc.20220—
+8K220259ALLY Adaptive Cataract Treatment SystemLensar, Inc.20220—
+8K213261EpilMENeauvia North America20220—
+8K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+8K213039Micro-current facial cold and hot service (model: TPML-100)Li-Tek Electronics Technology C0., Ltd.20224—
+8K213559FEMTO LDV Z8 Femtosecond Surgical LaserSie Ag,Surgical Instrument Engineering20221—
+8K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+8K211639BTL-785WBTL Industries, Inc.20227—
+8K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+8K212771LightStim ElipsaLed Intellectual Properties, LLC20221—
+8K212107ReversoIntelis Instruments, Ltd.20211—
+8K203214DemarkQ WOW, DemarkQ POPShenzhen Kaiyan Medical CO, Ltd.202121—
+8K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+8K210535UltraLight LED SystemRohrer Aesthetics, LLC20210—
+8K202955Contour Light CL-100Contour Research, LLC20218—
+8K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+8K193266MIINMedico USA, Inc.20210—
+8K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+8K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+8K200724VICTUS Femtosecond Laser PlatformTechnolas Perfect Vision GmbH20200—
+8K192275invisa-RED ELITEIR Technology, LLC20201—
+8K201406PicowonWontech Co., Ltd.20200—
+8K200736Stardust MedI.T.S. Group S.R.L.20200—
+8K200786Venus EpileveVenus Concept USA, Inc.20200—
+8K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+8K200751Photodynamic Therapy (PDT) EquipmentShangdong Huamei Technology Co., Ltd.20201—
+8K200659Dermalux Tri-Wave MDAesthetic Technology, Ltd.20203—
+8K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+8K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+8K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+8K192545PotenzaJeisys Medical Incorporated202020—
+8K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+8K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+8K192755Soli-Lite LG4 GalileoSilhouet-Tone Corporation20193—
+8K192521Intense Pulsed Light Treatment SystemShangdong Huamei Technology Co., Ltd.20193—
+8K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+8K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+8K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc.20190—
+8K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+8K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+8K181868SHINY RPL SystemIds, Ltd.20181—
+8K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+8K180338CellulizeWard Photonics, LLC20182—
+8K181430LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc.20182—
+8K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+8K181659Avologi ENEOPremier North America, Inc.20184—
+8K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+8K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+8K173503Pollogen Legend SystemPollogen, Ltd.20183—
+8K180593Vbeam Prima Laser SystemSyneron-Candela20182—
+8K180447reVive Light Therapy LED Cleansing SystemLed Technologies, Inc.201835—
+8K172555Sapphire, Elevare SapphireOmm Imports, Inc. D/B/A Zero Gravity201852—
+8K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+8K180320dpl IIa PanelLed Technologies, Inc.201814—
+8K180406Ellipse YdunEllipse A/S20180—
+8K173199PicoSure WorkstationCynosure, Inc.20189—
+8K172819LightWalker Laser System FamilyFotona D.O.O.201720—
+8K172111Vevazz LEDVevazz, LLC20170—
+8K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+8K162652Smart Photon Micro-current Device, Model: EP-300Li-Tek Electronic Technology Corporation201710—
+8K171702Exciplex308nmClarteis20175—
+8K161434Photon Vibrating massage Facial Aesthetic Device (Model: UI-200)Li-Tek Electronics Technologies20173—
+8K172096FraxisIlooda Co,., Ltd.20172—
+8K170187Photodynamic Therapy DeviceUvbiotek, LLC20170—