510(k) Report

Devices descending from K963339

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+5K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+5K221761SoleaConvergent Dental, Inc.202201
+5K213332Multifrax Laser SystemParadigm Medical Corporation20220—
+5K210084SilkroHironic Co., Ltd.20223—
+5K211534RevoLix HTLLisa Laser Products GmbH20220—
+5K210183Waterlase iPLusBiolase, Inc.20220—
+5K212492Frax 1940 for Nordlys and Frax ProCandela Corporation20210—
+5K212703AcuPulse CO2 Laser System, Delivery Devices and AccessoriesLumenis, Ltd.20210—
+5K211444CellFX SystemPulse Biosciences, Inc.20213—
+5K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+5K210925Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser…Boston Scientific202117
+5K202988Tixel SystemNovoxel, Ltd.20211—
+5K193201BTL-785FBtl20208—
+5K201663AcuPulse W CO2 Laser Systems, Delivery Devices and AccessoriesLumenis, Ltd.20202—
+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—
+5K192528CO2 Laser Therapy SystemShangdong Huamei Technology Co., Ltd.20198—
+5K192331LaseMD LEO Laser SystemLutronic Global20190—
+5K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+5K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+5K182173Joule SystemSciton, Inc20195—
+5K173827LightScalpelLightscalpel, LLC20180—
+5K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+5K173359Fractional CO2 Surgical Laser SystemAmi, Inc.20180—
+5K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+5K180508Joule SystemSciton, Inc20183—
+5K180423Empower H65Quanta System Spa20181—
+5K180406Ellipse YdunEllipse A/S20180—
+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—
+5K162398CO2 Laser Therapy SystemsBeijing Sincoheren Science and Technology Development Co.20172—
+5K171009LASEMD Laser SystemLutronic Corporation20178—
+5K163449HyPHo Laser SystemHyper Photonics Srl20170—
+5K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+5K163197Cook Holmium Laser FiberCook Incorporated20170—
+5K163196ACTION II Laser SystemLutronic Corporation20170—
+5K170121Lumenis Family of Holmium Surgical Lasers and Delivery Devices and AccessoriesLumenis, Ltd.2017171
+5K161257MultiPulse HoPLUSAsclepion Laser Technologies GmbH20171—
+5K170331Cyber HoQuanta System Spa20179—
+5K163009LithoQuanta System Spa201612—
+5K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+5K152703PlasmaBlade TnA Tonsil and Adenoid Dissection DeviceMedtronic Advanced Energy20160—
+5K153717Venus Versa SystemVenus Concept, Ltd.20161—
+5K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+5K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+5K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+5K152591Medilas H RFID Laser FibersDornier Medtech America, Inc.20151—
+5K150297PlasmaBlade UPPP and Suction CoagulatorMedtronic Advanced Energy20150—
+5K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+5K141237Harmony LiteAlma, Inc.20154—
+5K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+5K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+5K123353Ciq Controller, Ciq WandsArthroCare Corporation20130—
+5K130344Dornier Medilas UropulseDornier Medtech America, Inc.20130—
+5K122159Dornier Medilas H30 SolvoDornier Medtech America, Inc.20132—
+5K123385Medilas H Laser FibersDornier Medtech America, Inc.20120—
+5K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+5K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+5K110685Flexiva TractipBoston Scientific Corp20112—
+5K110686AccutracBoston Scientific Corp20110—
+5K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+5K093545Pinpointe Footlaser Model 6W, 30W, 100WIncisive, Inc. (Formerly Named Incisive, LLC)2010122—
+5K093547Pinpointe FootlaserPinpointe USA, Inc.2010115—
+5K100543Medississ Reprocessedent Ablation Wands (Coblators), Model#EIC8872-01Medisiss201001
+5K070374Arthrocare Ent Plasma WandArthrocare Corp.2007391
+5K021777Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and…Gyrus Ent LLC200276—
+5K021364Modification to Entec Plasma WandsArthrocare Corp.200294—
+5K020622Arthrocare Controller (System 2000 and 8000); Arthrocare Cable; Foot Control; Power…Arthrocare Corp.20021—
+6K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+6K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+6K260100MOSES Raydar™Boston Scientific Corporation20260—
+6K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+6K253633Holmium Laser Therapeutic Apparatus (HZ-40)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.20260—
+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—
+6K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+6K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+6K251759Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser…Boston Scientific Corporation20250—
+6K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+6K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+6K243139Reverso Pro SystemIndiba S. A. U.20250—
+6K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+6K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System…Beijing Adss Development Co., Ltd.20241—
+6K233123SilkroHironic Co., Ltd.20241—
+6K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+6K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+6K233099GladiatorRohrer Aesthetics, LLC20240—
+6K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+6K233473Deka LotusEl.En S.P.A.20241—
+6K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+6K233143PiXel8-RevealRohrer Aesthetics20240—
+6K232106Air Gap FiberWontech Co., Ltd.20240—
+6K233147PiXel8-RFRohrer Aesthetics20230—
+6K232192Venus Versa PRO SystemVenus Concept, Inc.20230—