510(k) Report

Devices descending from K946304

1,420 later devices reach Coherent Family of CO2 Surgical Laser Scanner Handpieces through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K240752Deka ToroEl.En S.P.A.20240—
+6K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+6K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+6K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+6K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+6K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+6K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+6K231894LED Spectrum therapy instrumentShenzhenshi Sincoheren S&T Development Co., Ltd.20230—
+6K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+6K231718Holmium Medical LaserAllengers Global Healthcare Private Limited20230—
+6K231394Intense Pulsed Light SystemSmedtrum Medical Technology Co., Ltd.20232—
+6K230077LaserMENeauvia North America20232—
+6K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+6K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+6K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+6K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+6K222685NIRA Model 2Dermal Photonics Corp20230—
+6K222221Deka HelixEl.En Electronic Engineering Spa20231—
+6K223647CLEAR+BRILLIANT TOUCH® Laser SystemSolta Medical, Inc.20220—
+6K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+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—
+6K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+6K221761SoleaConvergent Dental, Inc.202201
+6K213252Dornier ThulioDornier Medtech America, Inc.20220—
+6K213332Multifrax Laser SystemParadigm Medical Corporation20220—
+6K210084SilkroHironic Co., Ltd.20223—
+6K213039Micro-current facial cold and hot service (model: TPML-100)Li-Tek Electronics Technology C0., Ltd.20224—
+6K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+6K210183Waterlase iPLusBiolase, Inc.20220—
+6K212771LightStim ElipsaLed Intellectual Properties, LLC20221—
+6K212492Frax 1940 for Nordlys and Frax ProCandela Corporation20210—
+6K210847UltraClear Fractional Laser SystemFa International, LP20210—
+6K212607DarwinLuvo Medical Technologies, Inc.20210—
+6K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+6K212703AcuPulse CO2 Laser System, Delivery Devices and AccessoriesLumenis, Ltd.20210—
+6K211444CellFX SystemPulse Biosciences, Inc.20213—
+6K203214DemarkQ WOW, DemarkQ POPShenzhen Kaiyan Medical CO, Ltd.202121—
+6K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+6K210535UltraLight LED SystemRohrer Aesthetics, LLC20210—
+6K202955Contour Light CL-100Contour Research, LLC20218—
+6K202702FLARE Single-Use Surgical Laser FiberRealton (Suzhou) Medical Technology Co., Ltd.20210—
+6K202988Tixel SystemNovoxel, Ltd.20211—
+6K202006ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter…ArthroCare Corporation20202—
+6K193201BTL-785FBtl20208—
+6K192275invisa-RED ELITEIR Technology, LLC20201—
+6K201663AcuPulse W CO2 Laser Systems, Delivery Devices and AccessoriesLumenis, Ltd.20202—
+6K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+6K200751Photodynamic Therapy (PDT) EquipmentShangdong Huamei Technology Co., Ltd.20201—
+6K200659Dermalux Tri-Wave MDAesthetic Technology, Ltd.20203—
+6K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+6K191065Venus VivaTMVenus Concept USA, Inc.20200—
+6K192951Ellipse Frax 1940 for Ellipse Nordlys and Ellipse YdunEllipse A/S20201—
+6K193367elysion-proHigh Technology Products S.L.U20203—
+6K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+6K193426Elite iQCynosure, LLC20201—
+6K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+6K192027WEREWOLF COBLATION System, COBLATION HALO WandArthroCare Corporation20193—
+6K192755Soli-Lite LG4 GalileoSilhouet-Tone Corporation20193—
+6K192521Intense Pulsed Light Treatment SystemShangdong Huamei Technology Co., Ltd.20193—
+6K192528CO2 Laser Therapy SystemShangdong Huamei Technology Co., Ltd.20198—
+6K192331LaseMD LEO Laser SystemLutronic Global20190—
+6K191942MT One DiamondM&T S.R.L.20191—
+6K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+6K183647SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed…Olympus Surgical Technologies America2019124
+6K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+6K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+6K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc.20190—
+6K182173Joule SystemSciton, Inc20195—
+6K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+6K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+6K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+6K181868SHINY RPL SystemIds, Ltd.20181—
+6K180338CellulizeWard Photonics, LLC20182—
+6K173827LightScalpelLightscalpel, LLC20180—
+6K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+6K181659Avologi ENEOPremier North America, Inc.20184—
+6K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+6K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+6K173359Fractional CO2 Surgical Laser SystemAmi, Inc.20180—
+6K180447reVive Light Therapy LED Cleansing SystemLed Technologies, Inc.201835—
+6K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+6K172555Sapphire, Elevare SapphireOmm Imports, Inc. D/B/A Zero Gravity201852—
+6K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+6K180320dpl IIa PanelLed Technologies, Inc.201814—
+6K180426Empower H35Quanta System Spa20181—
+6K180406Ellipse YdunEllipse A/S20180—
+6K180350Dornier Medilas H Solvo 35 LaserDornier Medtech America20180—
+6K172647Reprocessed ArthroCare ENT CoblatorRenovo, Inc.20180—
+6K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+6K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+6K172111Vevazz LEDVevazz, LLC20170—
+6K162652Smart Photon Micro-current Device, Model: EP-300Li-Tek Electronic Technology Corporation201710—
+6K171702Exciplex308nmClarteis20175—
+6K161434Photon Vibrating massage Facial Aesthetic Device (Model: UI-200)Li-Tek Electronics Technologies20173—
+6K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+6K172025Litho 60Quanta System Spa20178—
+6K170187Photodynamic Therapy DeviceUvbiotek, LLC20170—
+6K162398CO2 Laser Therapy SystemsBeijing Sincoheren Science and Technology Development Co.20172—
+6K171009LASEMD Laser SystemLutronic Corporation20178—