510(k) Report

Devices descending from K951812

1,418 later devices reach Modified Coherent Ultrapulse CO2 Surgical Lasers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+5K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+5K234057NirvanaEl.En S.P.A.20240—
+5K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+5K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+5K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+5K232106Air Gap FiberWontech Co., Ltd.20240—
+5K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+5K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+5K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+5K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+5K230077LaserMENeauvia North America20232—
+5K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+5K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+5K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+5K231309SCAR 3El.En Electroinc Engineering Spa20230—
+5K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+5K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+5K222685NIRA Model 2Dermal Photonics Corp20230—
+5K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+5K221873NeoGen PSR SystemEnergist Limited20230—
+5K222221Deka HelixEl.En Electronic Engineering Spa20231—
+5K223647CLEAR+BRILLIANT TOUCH® Laser SystemSolta Medical, Inc.20220—
+5K22079410PLTentech Co., Ltd.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—
+5K212790XLase PlusBiotec Italia, Srl20220—
+5K213332Multifrax Laser SystemParadigm Medical Corporation20220—
+5K211652Renuvion Dermal Handpiece, Renuvion Dermal SystemApyx Medical Corporation (Formerly Bovie Medical Corporation20220—
+5K211534RevoLix HTLLisa Laser Products GmbH20220—
+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—
+5K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+5K212492Frax 1940 for Nordlys and Frax ProCandela Corporation20210—
+5K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+5K202288FinebeamSNJ Co., Ltd.20212—
+5K211444CellFX SystemPulse Biosciences, Inc.20213—
+5K203728DarwinLuvo Medical Technologies, Inc.20211—
+5K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+5K210925Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser…Boston Scientific202117
+5K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+5K203054FlexSysGme German Medical Engineering GmbH20210—
+5K202988Tixel SystemNovoxel, Ltd.20211—
+5K202361UltraSlim Digital, UltraSmooth DigitalWard Photonics, LLC20200—
+5K202172StarWalkerFotona D.O.O.20203—
+5K193201BTL-785FBtl20208—
+5K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+5K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+5K200616E>EyeCE-Swin20200—
+5K200746IPL Treatment SystemsShanghai Apolo Medical Technology Co., Ltd.20205—
+5K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+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—
+5K192331LaseMD LEO Laser SystemLutronic Global20190—
+5K191693BC-5Reveallux, Corp20190—
+5K183708Poly ClearMedtek Skincare, LLC201922—
+5K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+5K190938Phototherapy SystemShanghai Apolo Medical Technology Co., Ltd.201916—
+5K182173Joule SystemSciton, Inc20195—
+5K173827LightScalpelLightscalpel, LLC20180—
+5K180900LED Light Therapy DeviceUvbiotek, LLC201829—
+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—
+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—
+5K172413MT ONEM&T S.R.L.20175—
+5K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+5K171227StarWalkerFotona D.O.O.20177—
+5K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+5K172096FraxisIlooda Co,., Ltd.20172—
+5K171055Philips BlueControlPhilips Electronics Nederland B.V.20171—
+5K171009LASEMD Laser SystemLutronic Corporation20178—
+5K163449HyPHo Laser SystemHyper Photonics Srl20170—
+5K170325Secret RFIlooda Co,., Ltd.201710—
+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—
+5K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+5K161941Pulsaderm Acne DeviceNutra Luxe MD, LLC20164—
+5K161925CO2 Laser Therapy MachineBeijing Adss Development Co., Ltd.201614—
+5K160880Photonica ProfessionalWard Photonics, LLC20166—
+5K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+5K152703PlasmaBlade TnA Tonsil and Adenoid Dissection DeviceMedtronic Advanced Energy20160—
+5K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+5K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+5K153566Magma SystemFormatk Systems, Ltd.20162—
+5K153717Venus Versa SystemVenus Concept, Ltd.20161—
+5K151337StrialiteCentre Light Solutions, LLC20160—
+5K153081Clear Bi-LightMichael Todd, LP201646—
+5K152790Venus Versa SystemVenus Concept, Ltd.20160—