510(k) Report

Devices descending from K912029

676 later devices reach Ultrapulse (TM) Carbon Dioxide Surgical Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+6K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+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—
+6K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+6K103626Cutera Genesisplus Laser SystemCutera, Inc.2011121—
+6K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+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—
+7K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+7K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.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—
+7K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+7K251996ENTire IRE SystemEntire Medical, Ltd.20261—
+7K251303Tamburo Thulium Fiber Laser SystemMenovex Medical Technology (Shenzhen) Co., Ltd.20250—
+7K251824Patriot DuoPatriot Laser, LLC20250—
+7K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+7K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+7K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+7K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+7K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+7K243139Reverso Pro SystemIndiba S. A. U.20250—
+7K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+7K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+7K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System…Beijing Adss Development Co., Ltd.20241—
+7K233123SilkroHironic Co., Ltd.20241—
+7K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+7K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+7K233099GladiatorRohrer Aesthetics, LLC20240—
+7K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+7K233473Deka LotusEl.En S.P.A.20241—
+7K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+7K233143PiXel8-RevealRohrer Aesthetics20240—
+7K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+7K233147PiXel8-RFRohrer Aesthetics20230—
+7K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+7K223727LavieenWontech Co., Ltd.20234—
+7K230914ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System…ArthroCare Corporation20230—
+7K223033Tixel® 2 SystemNovoxel, Ltd.20230—
+7K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+7K230308Alma HarmonyAlma Lasers, Inc.20232—
+7K223680Eneka ProTermosalud20230—
+7K221306SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed…Gyrus Acmi, Inc.202348
+7K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+7K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+7K222369PURE LaserEndymed Medical, Ltd.20220—
+7K213674CellFX SystemPulse Biosciences, Inc.20220—
+7K222075CellFX SystemPulse Biosciences, Inc.20220—
+7K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+7K221671CellFX® SystemPulse Biosciences, Inc.20220—
+7K211000AcutronIlooda Co,., Ltd.20220—
+7K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+7K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+7K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+7K211639BTL-785WBTL Industries, Inc.20227—
+7K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+7K212611CO2 Laser EquipmentBeijing Globalipl Development Co., Ltd.20220—
+7K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+7K212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc.20220—
+7K210847UltraClear Fractional Laser SystemFa International, LP20210—
+7K212107ReversoIntelis Instruments, Ltd.20211—
+7K211517Optica XT Thulium Fiber Laser and Accessories, also known as Optica XT, Optica XT…Convergent Laser Technologies20210—
+7K203728DarwinLuvo Medical Technologies, Inc.20211—
+7K211401SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser…Gyrus Acmi, Inc.202171
+7K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+7K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+7K202250Dermatological Carbon Dioxide Laser SystemsZhuolu Jontelaser Manufacturing Technology Co., Ltd.20200—
+7K202428AcuPulse W CO2 Laser Systems, Delivery Devices and AccessoriesLumenis, Ltd.20201—
+7K200042CO2 Laser SystemBeijing Superlaser Technology Co., Ltd.20205—
+7K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+7K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+7K192600Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60Quanta System Spa20205—
+7K192545PotenzaJeisys Medical Incorporated202020—
+7K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+7K192990Litho EvoQuanta System Spa20190—
+7K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+7K191518CO2 Laser SystemShenzhen Gsd Tech Co., Ltd.20191—
+7K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+7K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+7K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+7K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+7K173503Pollogen Legend SystemPollogen, Ltd.20183—
+7K180922Empower H100, Cyber Ho 100, Litho 100Quanta System Spa20186—
+7K171227StarWalkerFotona D.O.O.20177—
+7K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+7K152744Diego Elite DrillGyrus Acmi, Inc.20160—
+7K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+7K151743THUNDERBEAT Open Fine JawOlympus Medical Systems Corp.20166—
+7K152702Ent Biotech Solutions Tissue Removal Device (Elasso)Ent Biotech Solutions20160—