510(k) Report

Devices descending from K951034

314 later devices reach Aura Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+5K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+5K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+5K213467EVA NEXUS Ophthalmic Surgical SystemD.O.R.C. Dutch Ophthalmic Research Center (International)202216
+5K210183Waterlase iPLusBiolase, Inc.20220—
+5K212241Quatera 700Carl Zeiss Meditec, AG20221—
+5K193266MIINMedico USA, Inc.20210—
+5K201406PicowonWontech Co., Ltd.20200—
+5K193367elysion-proHigh Technology Products S.L.U20203—
+5K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+5K190875EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC…D.O.R.C. Dutch Ophthalmic Research Center (International)201921
+5K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+5K180508Joule SystemSciton, Inc20183—
+5K173199PicoSure WorkstationCynosure, Inc.20189—
+5K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+5K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+5K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+5K162755PicocareWontech Co., Ltd.20179—
+5K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+5K170520HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy…Alcon Research, Ltd.20171—
+5K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+5K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+5K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+5K152856Helios IIILaseroptek Co., Ltd.20165—
+5K160480PicoSure WorkstationCynosure, Inc.201620—
+5K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+5K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+5K150326PicoWay Laser SystemCandela Corporation201568—
+5K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+5K141237Harmony LiteAlma, Inc.20154—
+5K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+5K143105Picosure WorkstationCynosure, Inc.201549—
+5K142372Pico Way Laser SystemCandela Corpation201470—
+5K140719Picosure WorkstationCynosure, Inc.201450—
+5K141065Constellation Vision SystemAlcon Research, Ltd.201426
+5K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+5K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+5K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+5K121555Centurion Vision SystemAlcon Laboratories, Inc.201264
+5K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+5K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+6K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+6K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+6K250501System SophiThis AG20250—
+6K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+6K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+6K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+6K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+6K230858Quatera 700Carl Zeiss Meditec, AG20230—
+6K223680Eneka ProTermosalud20230—
+6K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+6K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+6K222369PURE LaserEndymed Medical, Ltd.20220—
+6K212663Helios IV 785Laseroptek Co., Ltd.20223—
+6K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+6K220030Vista Ophthalmics Vitrectomy ProbeVista Ophthalmics, LLC20220—
+6K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+6K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+6K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+6K210847UltraClear Fractional Laser SystemFa International, LP20210—
+6K203728DarwinLuvo Medical Technologies, Inc.20211—
+6K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+6K210226PicoSure WorkstationCynosure, LLC20213—
+6K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+6K202172StarWalkerFotona D.O.O.20203—
+6K193376Visalis V500, Visalis S500Carl Zeiss Meditec, AG20200—
+6K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+6K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+6K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+6K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+6K191685PicoWay Laser SystemCandela Corporation201920—
+6K181602Pioneer Elite Diode LaserCAO Group, Inc.20190—
+6K181601Precise SHP Diode LaserCAO Group, Inc.20191—
+6K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+6K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+6K182997enlighten III Laser SystemCutera, Inc.20180—
+6K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+6K181272Picocare FamilyWontech Co., Ltd.20188—
+6K173700PICOPLUS Laser SystemLutronic Corporation20187—
+6K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+6K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+6K171986Sterling Supreme Diode LaserCAO Group, Inc.20171—
+6K171227StarWalkerFotona D.O.O.20177—
+6K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+6K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+6K161794CENTURION Vision System (Active SentryTM)Alcon Research, Ltd.20173—
+6K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+6K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+6K160368EVO platformQuanta System Spa201636—
+6K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+6K152714Quanta ForteQuanta System Spa201513—
+6K152012EVO platformQuanta System Spa201537—
+6K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+6K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+6K142226Pilot Ultra Diode LaserCAO Group, Inc.20140—
+6K142225Pilot Elite Diode LaserCAO Group, Inc.20140—
+6K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+7K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+7K261570Picosure WorkstationCynosure, LLC20260—
+7K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—