510(k) Report

Devices descending from K974789

653 later devices reach Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K222221Deka HelixEl.En Electronic Engineering Spa20231—
+5K223647CLEAR+BRILLIANT TOUCH® Laser SystemSolta Medical, Inc.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—
+5K213252Dornier ThulioDornier Medtech America, Inc.20220—
+5K213332Multifrax Laser SystemParadigm Medical Corporation20220—
+5K220467The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and…Lumenis Be, Ltd.20220—
+5K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+5K210183Waterlase iPLusBiolase, Inc.20220—
+5K212492Frax 1940 for Nordlys and Frax ProCandela Corporation20210—
+5K211444CellFX SystemPulse Biosciences, Inc.20213—
+5K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+5K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+5K202702FLARE Single-Use Surgical Laser FiberRealton (Suzhou) Medical Technology Co., Ltd.20210—
+5K202988Tixel SystemNovoxel, Ltd.20211—
+5K202006ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter…ArthroCare Corporation20202—
+5K193201BTL-785FBtl20208—
+5K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+5K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+5K192856MT OneM&T S.R.L.20202—
+5K191065Venus VivaTMVenus Concept USA, Inc.20200—
+5K192951Ellipse Frax 1940 for Ellipse Nordlys and Ellipse YdunEllipse A/S20201—
+5K193367elysion-proHigh Technology Products S.L.U20203—
+5K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+5K200234Surgical laser fibersQuanta System Spa20202—
+5K192027WEREWOLF COBLATION System, COBLATION HALO WandArthroCare Corporation20193—
+5K192331LaseMD LEO Laser SystemLutronic Global20190—
+5K183647SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed…Olympus Surgical Technologies America2019124
+5K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+5K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc.20190—
+5K182173Joule SystemSciton, Inc20195—
+5K173827LightScalpelLightscalpel, LLC20180—
+5K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+5K173359Fractional CO2 Surgical Laser SystemAmi, Inc.20180—
+5K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+5K180508Joule SystemSciton, Inc20183—
+5K180597AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUOLumenis, Ltd.20183—
+5K180426Empower H35Quanta System Spa20181—
+5K180406Ellipse YdunEllipse A/S20180—
+5K180350Dornier Medilas H Solvo 35 LaserDornier Medtech America20180—
+5K172647Reprocessed ArthroCare ENT CoblatorRenovo, Inc.20180—
+5K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+5K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+5K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+5K172096FraxisIlooda Co,., Ltd.20172—
+5K172025Litho 60Quanta System Spa20178—
+5K171009LASEMD Laser SystemLutronic Corporation20178—
+5K170325Secret RFIlooda Co,., Ltd.201710—
+5K163196ACTION II Laser SystemLutronic Corporation20170—
+5K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+5K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+5K161771Medilas H Laser FibersDornier Medtech America, Inc.20160—
+5K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+5K153717Venus Versa SystemVenus Concept, Ltd.20161—
+5K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+5K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+5K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+5K151306SoleaConvergent Dental, Inc.20151—
+5K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+5K141237Harmony LiteAlma, Inc.20154—
+5K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+5K142999EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma Wand with Integrated…ArthroCare Corporation201443
+5K132754Neogen PSR SystemEnergist, Ltd.20132—
+5K131805Inpulse LaserIncisive, Inc.20130—
+5K130420SOLEAConvergent Dental, Inc.201321
+5K122652Arthrocare Turbinator WandArthroCare Corporation20133—
+5K130413Pinpointe FootlaserNuvolase, Inc.20130—
+5K121508Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-NFotona D.D.20121—
+5K121977Plasmajet Neutral Plasma Surgery SystemPlasma Surgical Limited20121—
+5K120938The PL-1064 Laser SystemSheaumann Laser, Inc.201214—
+5K120235Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo…Aerolase Medical Lasers, LLC201233—
+5K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+5K113702Fotona XP ND: Yag Laser SystemFotona D.D.201265—
+5K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+5K110375Blueshine's Gold SeriesBlueshine Srl20124—
+5K111483Joule Clearsense Laser SystemSciton, Inc20110—
+5K103338CooltouchNew Star Lasers, Inc.201101
+5K110370Q-ClearLight Age, Inc.201135—
+5K110897Cortex CO2 / ER:Yag Laser SystemSandstone Medical Technologies, LLC20112—
+5K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+5K103626Cutera Genesisplus Laser SystemCutera, Inc.2011121—
+5K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+5K100597Harmonic Focus ShearsEthicon Endo-Surgery, LLC201018—
+5K083415Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection DevicePeak Surgical, Inc.20098—
+5K041633Gyrus Plasmacision Laparoscopic SpatulaGyrus Medical, Inc.20048—
+5K041285Gyrus G3 System (Generator, Assessories, Somnoplasty Electrodes and Plasmacision…Gyrus Medical, Ltd.2004202
+5K034004Diego RF Powered Dissector and Drill System ConsoleGyrus Ent LLC200450—
+5K030108Arthrocare Ent Coblator Surgery SystemArthrocare Corp.2003921
+5K022475Modification to Arthrocare Controller (System 2000 and 8000), Arthrocare Patient Cable…Arthrocare Corp.20020—
+6K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+6K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+6K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+6K253917ARION ARC SystemPlasma Surgical, Inc.20260—
+6K253680LYNX COBLATION Laryngeal Wand (72290254)ArthroCare Corporation20260—
+6K252971Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (Laser…C.R. Bard, Inc.20260—
+6K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+6K251996ENTire IRE SystemEntire Medical, Ltd.20261—
+6K251303Tamburo Thulium Fiber Laser SystemMenovex Medical Technology (Shenzhen) Co., Ltd.20250—
+6K251824Patriot DuoPatriot Laser, LLC20250—
+6K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—