510(k) Report

Devices descending from K961748

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+6K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+6K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+6K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+6K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+6K233143PiXel8-RevealRohrer Aesthetics20240—
+6K232117Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)Wuhan Lotuxs Technology Co., Ltd.20231—
+6K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+6K230077LaserMENeauvia North America20232—
+6K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+6K213669Lightscalpel LS-4020Lightscalpel, Inc.20230—
+6K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+6K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+6K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+6K221761SoleaConvergent Dental, Inc.202201
+6K213350mJOULE System and AccessoriesSciton, Inc20220—
+6K220020Cryo 7Zimmer Medizinsysteme GmbH20222—
+6K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+6K210847UltraClear Fractional Laser SystemFa International, LP20210—
+6K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+6K202288FinebeamSNJ Co., Ltd.20212—
+6K212607DarwinLuvo Medical Technologies, Inc.20210—
+6K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+6K211444CellFX SystemPulse Biosciences, Inc.20213—
+6K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+6K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+6K203054FlexSysGme German Medical Engineering GmbH20210—
+6K202988Tixel SystemNovoxel, Ltd.20211—
+6K202361UltraSlim Digital, UltraSmooth DigitalWard Photonics, LLC20200—
+6K202172StarWalkerFotona D.O.O.20203—
+6K193201BTL-785FBtl20208—
+6K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+6K200746IPL Treatment SystemsShanghai Apolo Medical Technology Co., Ltd.20205—
+6K191065Venus VivaTMVenus Concept USA, Inc.20200—
+6K193367elysion-proHigh Technology Products S.L.U20203—
+6K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+6K193426Elite iQCynosure, LLC20201—
+6K191693BC-5Reveallux, Corp20190—
+6K191942MT One DiamondM&T S.R.L.20191—
+6K183708Poly ClearMedtek Skincare, LLC201922—
+6K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+6K190938Phototherapy SystemShanghai Apolo Medical Technology Co., Ltd.201916—
+6K173827LightScalpelLightscalpel, LLC20180—
+6K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+6K180900LED Light Therapy DeviceUvbiotek, LLC201829—
+6K173359Fractional CO2 Surgical Laser SystemAmi, Inc.20180—
+6K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+6K173677InMode VLazeInmode MD, Ltd.20183—
+6K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+6K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+6K170179LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer InfinityLumenis, Ltd.201714—
+6K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+6K171227StarWalkerFotona D.O.O.20177—
+6K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+6K171055Philips BlueControlPhilips Electronics Nederland B.V.20171—
+6K163551LenSx Laser SystemAlcon Laboratories, Inc.20173—
+6K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+6K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+6K160312Fraxis DuoIlooda Co,., Ltd.201614—
+6K161941Pulsaderm Acne DeviceNutra Luxe MD, LLC20164—
+6K160880Photonica ProfessionalWard Photonics, LLC20166—
+6K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+6K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+6K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+6K153566Magma SystemFormatk Systems, Ltd.20162—
+6K153717Venus Versa SystemVenus Concept, Ltd.20161—
+6K153081Clear Bi-LightMichael Todd, LP201646—
+6K152790Venus Versa SystemVenus Concept, Ltd.20160—
+6K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+6K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+6K152012EVO platformQuanta System Spa201537—
+6K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+6K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+6K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+6K151161VICTUS Femtosecond Laser PlatformTechnolas Perfect Vision GmbH20152—
+6K140386Lumina 24Rogers Sciences, Inc.20150—
+6K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+6K143010LENSAR Laser System - fs 3DLensar, Inc.20153—
+6K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+6K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+6K142256Applied BioPhotonics Phototherapy System ABPT1003Applied Biophotonics, Ltd.20150—
+6K141852Ifs Advanced Femtosecond Laser SystemAmo Manufacturing USA, LLC20155—
+6K142340Infrared Therapy SystemBeijing Huatai Healthcare Technology Co., Ltd.20140—
+6K142093V20 SystemViora, Ltd.201432—
+6K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+6K141555AdvantageLutronic Corporation201414—
+6K141476Wavelight FS200 Laser SystemAlcon Research, Ltd. Dba Alcon Laboratories, Inc.20148—
+6K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+6K133364Picosure WorkstationCynosure, Inc.201451—
+6K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+6K133774AtovenBio-Med USA, Inc.20146—
+6K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+6K132534Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH20145—
+6K124064Young AgainEspansione Marketing S.P.A20131—
+6K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+6K131142Genesis Led WandsGenesis Biosystems, Inc.20130—
+6K130459Tria Fan SystemTria Beauty, Inc.20131—
+6K131859Multifunctional SeriesBeijing Honkon Technologies Co., Ltd.20133—
+6K123999Illumask Acne Light Therapy MaskLa Lumiere, LLC2013112—
+6K122493GenesisplusCutera, Inc.201318—