510(k) Report

Devices descending from K963339

675 later devices reach Coherent Ultrapulse CO2 Surgical Lasers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K223727LavieenWontech Co., Ltd.20234—
+6K231718Holmium Medical LaserAllengers Global Healthcare Private Limited20230—
+6K223033Tixel® 2 SystemNovoxel, Ltd.20230—
+6K230308Alma HarmonyAlma Lasers, Inc.20232—
+6K223680Eneka ProTermosalud20230—
+6K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+6K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+6K222369PURE LaserEndymed Medical, Ltd.20220—
+6K213674CellFX SystemPulse Biosciences, Inc.20220—
+6K222075CellFX SystemPulse Biosciences, Inc.20220—
+6K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+6K221671CellFX® SystemPulse Biosciences, Inc.20220—
+6K213252Dornier ThulioDornier Medtech America, Inc.20220—
+6K211000AcutronIlooda Co,., Ltd.20220—
+6K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+6K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+6K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+6K211639BTL-785WBTL Industries, Inc.20227—
+6K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+6K212611CO2 Laser EquipmentBeijing Globalipl Development Co., Ltd.20220—
+6K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+6K210847UltraClear Fractional Laser SystemFa International, LP20210—
+6K212107ReversoIntelis Instruments, Ltd.20211—
+6K203728DarwinLuvo Medical Technologies, Inc.20211—
+6K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+6K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+6K202702FLARE Single-Use Surgical Laser FiberRealton (Suzhou) Medical Technology Co., Ltd.20210—
+6K202006ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter…ArthroCare Corporation20202—
+6K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+6K202250Dermatological Carbon Dioxide Laser SystemsZhuolu Jontelaser Manufacturing Technology Co., Ltd.20200—
+6K202428AcuPulse W CO2 Laser Systems, Delivery Devices and AccessoriesLumenis, Ltd.20201—
+6K200042CO2 Laser SystemBeijing Superlaser Technology Co., Ltd.20205—
+6K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+6K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+6K200234Surgical laser fibersQuanta System Spa20202—
+6K192545PotenzaJeisys Medical Incorporated202020—
+6K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+6K192027WEREWOLF COBLATION System, COBLATION HALO WandArthroCare Corporation20193—
+6K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+6K191518CO2 Laser SystemShenzhen Gsd Tech Co., Ltd.20191—
+6K183647SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed…Olympus Surgical Technologies America2019124
+6K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc.20190—
+6K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+6K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+6K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+6K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+6K173503Pollogen Legend SystemPollogen, Ltd.20183—
+6K180426Empower H35Quanta System Spa20181—
+6K180350Dornier Medilas H Solvo 35 LaserDornier Medtech America20180—
+6K172647Reprocessed ArthroCare ENT CoblatorRenovo, Inc.20180—
+6K171227StarWalkerFotona D.O.O.20177—
+6K172025Litho 60Quanta System Spa20178—
+6K161771Medilas H Laser FibersDornier Medtech America, Inc.20160—
+6K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+6K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+6K152714Quanta ForteQuanta System Spa201513—
+6K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+6K142999EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma Wand with Integrated…ArthroCare Corporation201443
+6K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+6K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+6K131805Inpulse LaserIncisive, Inc.20130—
+6K122652Arthrocare Turbinator WandArthroCare Corporation20133—
+6K130413Pinpointe FootlaserNuvolase, Inc.20130—
+6K121508Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-NFotona D.D.20121—
+6K120938The PL-1064 Laser SystemSheaumann Laser, Inc.201214—
+6K120235Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo…Aerolase Medical Lasers, LLC201233—
+6K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+6K113702Fotona XP ND: Yag Laser SystemFotona D.D.201265—
+6K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+6K110375Blueshine's Gold SeriesBlueshine Srl20124—
+6K111483Joule Clearsense Laser SystemSciton, Inc20110—
+6K103338CooltouchNew Star Lasers, Inc.201101
+6K110370Q-ClearLight Age, Inc.201135—
+6K103626Cutera Genesisplus Laser SystemCutera, Inc.2011121—
+6K100597Harmonic Focus ShearsEthicon Endo-Surgery, LLC201018—
+6K083415Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection DevicePeak Surgical, Inc.20098—
+6K041633Gyrus Plasmacision Laparoscopic SpatulaGyrus Medical, Inc.20048—
+6K041285Gyrus G3 System (Generator, Assessories, Somnoplasty Electrodes and Plasmacision…Gyrus Medical, Ltd.2004202
+6K034004Diego RF Powered Dissector and Drill System ConsoleGyrus Ent LLC200450—
+6K030108Arthrocare Ent Coblator Surgery SystemArthrocare Corp.2003921
+6K022475Modification to Arthrocare Controller (System 2000 and 8000), Arthrocare Patient Cable…Arthrocare Corp.20020—
+7K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+7K262269CO2 Laser System (MBT- CO2 Laser)Beijing Mega Beauty Technology Co., Ltd.20260—
+7K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+7K260257CO2 Laser SystemSanhe Meditech Co., Ltd.20260—
+7K253680LYNX COBLATION Laryngeal Wand (72290254)ArthroCare Corporation20260—
+7K252971Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (Laser…C.R. Bard, Inc.20260—
+7K253920CO2 Laser Treatment Machine (CFR3M1)Haidari Beauty Technology (Beijing) Co., Ltd.20260—
+7K251996ENTire IRE SystemEntire Medical, Ltd.20261—
+7K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+7K250998CO2 Laser Therapy System (Model: LFS-D9U)Sanhe Lefis Electronics Co., Ltd.20250—
+7K251303Tamburo Thulium Fiber Laser SystemMenovex Medical Technology (Shenzhen) Co., Ltd.20250—
+7K251824Patriot DuoPatriot Laser, LLC20250—
+7K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+7K251334New Doublo 2.0Hironic Co., Ltd.20250—
+7K251919Thulium Laser System (Deluxlase)Nanjing Bestview Laser S&T Co., Ltd.20250—
+7K242859VEGAIbramed Equipamentos Médicos20250—
+7K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+7K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+7K250281Deka LotusEl.En S.P.A.20250—