510(k) Report

Devices descending from K982816

973 later devices reach Vnus Closure System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+5K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+5K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+5K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+5K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+5K231894LED Spectrum therapy instrumentShenzhenshi Sincoheren S&T Development Co., Ltd.20230—
+5K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+5K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+5K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+5K222701MANTA LaserSqualus Med, Ltd.20222—
+5K22079410PLTentech Co., Ltd.20220—
+5K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+5K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+5K212790XLase PlusBiotec Italia, Srl20220—
+5K213039Micro-current facial cold and hot service (model: TPML-100)Li-Tek Electronics Technology C0., Ltd.20224—
+5K213594Echolaser X4Elesta S.P.A20221—
+5K210183Waterlase iPLusBiolase, Inc.20220—
+5K212771LightStim ElipsaLed Intellectual Properties, LLC20221—
+5K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+5K203214DemarkQ WOW, DemarkQ POPShenzhen Kaiyan Medical CO, Ltd.202121—
+5K203728DarwinLuvo Medical Technologies, Inc.20211—
+5K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+5K210535UltraLight LED SystemRohrer Aesthetics, LLC20210—
+5K202955Contour Light CL-100Contour Research, LLC20218—
+5K192275invisa-RED ELITEIR Technology, LLC20201—
+5K200616E>EyeCE-Swin20200—
+5K200751Photodynamic Therapy (PDT) EquipmentShangdong Huamei Technology Co., Ltd.20201—
+5K200659Dermalux Tri-Wave MDAesthetic Technology, Ltd.20203—
+5K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+5K193367elysion-proHigh Technology Products S.L.U20203—
+5K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+5K192755Soli-Lite LG4 GalileoSilhouet-Tone Corporation20193—
+5K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+5K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+5K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc.20190—
+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—
+5K180338CellulizeWard Photonics, LLC20182—
+5K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+5K181659Avologi ENEOPremier North America, Inc.20184—
+5K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+5K180447reVive Light Therapy LED Cleansing SystemLed Technologies, Inc.201835—
+5K180508Joule SystemSciton, Inc20183—
+5K172555Sapphire, Elevare SapphireOmm Imports, Inc. D/B/A Zero Gravity201852—
+5K180320dpl IIa PanelLed Technologies, Inc.201814—
+5K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+5K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+5K172111Vevazz LEDVevazz, LLC20170—
+5K162652Smart Photon Micro-current Device, Model: EP-300Li-Tek Electronic Technology Corporation201710—
+5K171702Exciplex308nmClarteis20175—
+5K172413MT ONEM&T S.R.L.20175—
+5K161434Photon Vibrating massage Facial Aesthetic Device (Model: UI-200)Li-Tek Electronics Technologies20173—
+5K171227StarWalkerFotona D.O.O.20177—
+5K170187Photodynamic Therapy DeviceUvbiotek, LLC20170—
+5K163137NIRA Beauty Skin LaserDermal Photonics Corporation20171—
+5K163196ACTION II Laser SystemLutronic Corporation20170—
+5K170111Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37Pulsaderm, LLC201745—
+5K170260BC-001+ Acne PurifierOriental Inspiration Limited20172—
+5K162784Silk'n HSTHome Skinovations, Ltd.20171—
+5K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+5K162098LED Phototherapy DeviceLi-Tek Electronic Technology Corporation201775—
+5K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+5K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+5K152280BioPhotas Celluma3Biophotas, Inc.201649—
+5K152332Perfectio LED infrared deviceOmm Imports Inc Dba Zero Gravity201661—
+5K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+5K143713Lustre PRO Light SystemAmbicare Health, Ltd.20162—
+5K152889Sonilase Blue, Sonilase Blue-Clean, Sonilase Blue-UV Clean PlusBiorenew Labs, LLC20153—
+5K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+5K152714Quanta ForteQuanta System Spa201513—
+5K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+5K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+5K151629Guardian 1000Quanta System Spa20150—
+5K150140MCL 31 DermablateAsclepion Laser Technologies GmbH20157—
+5K150282Shaser Skin Beauty Intense Pulsed Light System Family for AcneShaser, Inc.20150—
+5K150098LightStim Professional 2-Panel LightLed Intellectual Properties, LLC201510—
+5K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+5K140471Pro X Otc 5La Lumiere, LLC2015107—
+5K140120EPIC 10Biolase, Inc.20141—
+5K133546Starlite-OM, Light Effects, ThibiantPs Advanced Engineering20140—
+5K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+5K133774AtovenBio-Med USA, Inc.20146—
+5K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+5K133837Viora V-TotalViora, Ltd.201433—
+5K131113Biophotas CellumaBiophotas, Inc.201455—
+5K131461Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC201481—
+5K130459Tria Fan SystemTria Beauty, Inc.20131—
+5K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+5K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+5K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+5K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+5K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+5K121327Diolase 10SBiolase Technology, Inc.20132—
+5K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+5K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+5K110243Medart Diode Laser System & AccessoriesMedart A/S20110—
+5K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+5K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+5K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+5K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—