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
+6K260100MOSES Raydar™Boston Scientific Corporation20260—
+6K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+6K253917ARION ARC SystemPlasma Surgical, Inc.20260—
+6K252561BTL-754FFBTL Industries, Inc.20260—
+6K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+6K253633Holmium Laser Therapeutic Apparatus (HZ-40)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.20260—
+6K252519CO2 Laser Therapy System (K106)Hebei Keylaser Sci-Tech Co.,Ltd20250—
+6K252529Moses™ 200 D/F/L Laser Fiber (M0068130100); Moses™ 365 D/F/L Laser Fiber (M0068130110)…Boston Scientific Corporation20250—
+6K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+6K251759Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser…Boston Scientific Corporation20250—
+6K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+6K251632Optimas MAX SystemInMode, Ltd.20251—
+6K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+6K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+6K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+6K250183CO2 Laser System (CO2 Laser SST-L23)Zhuozhou Summer Star Technologies Co., Ltd.20250—
+6K250189AdvaTxAdvalight Aps20250—
+6K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+6K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+6K242941CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+6K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.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—
+6K233024Alma HarmonyAlma Lasers, Inc.20241—
+6K232106Air Gap FiberWontech Co., Ltd.20240—
+6K231718Holmium Medical LaserAllengers Global Healthcare Private Limited20230—
+6K230077LaserMENeauvia North America20232—
+6K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+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—
+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—
+6K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+6K210183Waterlase iPLusBiolase, Inc.20220—
+6K212492Frax 1940 for Nordlys and Frax ProCandela Corporation20210—
+6K212703AcuPulse CO2 Laser System, Delivery Devices and AccessoriesLumenis, Ltd.20210—
+6K211444CellFX SystemPulse Biosciences, Inc.20213—
+6K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+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—
+6K202988Tixel SystemNovoxel, Ltd.20211—
+6K202006ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter…ArthroCare Corporation20202—
+6K193201BTL-785FBtl20208—
+6K201663AcuPulse W CO2 Laser Systems, Delivery Devices and AccessoriesLumenis, Ltd.20202—
+6K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+6K192856MT OneM&T S.R.L.20202—
+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—
+6K200234Surgical laser fibersQuanta System Spa20202—
+6K192027WEREWOLF COBLATION System, COBLATION HALO WandArthroCare Corporation20193—
+6K192528CO2 Laser Therapy SystemShangdong Huamei Technology Co., Ltd.20198—
+6K192331LaseMD LEO Laser SystemLutronic Global20190—
+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—
+6K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc.20190—
+6K182173Joule SystemSciton, Inc20195—
+6K173827LightScalpelLightscalpel, LLC20180—
+6K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+6K173359Fractional CO2 Surgical Laser SystemAmi, Inc.20180—
+6K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+6K180508Joule SystemSciton, Inc20183—
+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—
+6K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+6K172025Litho 60Quanta System Spa20178—
+6K162398CO2 Laser Therapy SystemsBeijing Sincoheren Science and Technology Development Co.20172—
+6K171009LASEMD Laser SystemLutronic Corporation20178—
+6K163196ACTION II Laser SystemLutronic Corporation20170—
+6K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+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—
+6K153717Venus Versa SystemVenus Concept, Ltd.20161—
+6K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+6K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+6K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+6K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+6K141237Harmony LiteAlma, Inc.20154—
+6K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+6K142999EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma Wand with Integrated…ArthroCare Corporation201443
+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—