510(k) Report

Devices descending from K812219

297 later devices reach Model 900S Intraocular Probe through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+6K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+6K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+6K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+6K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+6K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+6K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+6K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+6K232051VISULAS greenCarl Zeiss Meditec20231—
+6K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+6K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+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—
+6K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+6K210183Waterlase iPLusBiolase, Inc.20220—
+6K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+6K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+6K203130Ophthalmic Yag Laser System YC-200Nidek Co., Ltd.20200—
+6K193367elysion-proHigh Technology Products S.L.U20203—
+6K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+6K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+6K190083Leaf PhotocoagulatorNorlase Aps20193—
+6K180508Joule SystemSciton, Inc20183—
+6K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+6K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+6K170302Yellow Laser Photocoagulator Ylc-500Nidek Co., Ltd.20171—
+6K162191NAVILAS Laser SystemOd-Os GmbH20161—
+6K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+6K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+6K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+6K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+6K141237Harmony LiteAlma, Inc.20154—
+6K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+6K133774AtovenBio-Med USA, Inc.20146—
+6K123542Pascal Synthesis (532NM/577NM) Opthalmic LaserTopcon Medical Laser Systems, Inc.201351
+6K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+6K121475Txcell Scanning Laser Delivery SystemIridex Corp20126—
+6K120825Supra Scan Delivery SystemQuantel Medical20121—
+6K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+6K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+6K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+6K100558Quanta Diode Laser SystemQuanta System Spa201068—
+6K100019Pascal Streamline PhotocoagulatorOptimedica Corporation2010161
+6K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+6K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+7K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+7K261964Echolaser X4Elesta S.P.A20260—
+7K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+7K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+7K252745Halo Sterile Single-use Radial Fiber…Micro-Energy Medical Technology Co., Ltd.20251—
+7K253007Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber…Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.20250—
+7K251772Navilas Laser System 577sl (156691)Od-Os GmbH20250—
+7K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+7K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+7K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+7K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+7K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+7K233911VISULAS combiCarl Zeiss Meditec, AG20240—
+7K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+7K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+7K233344Regenalase Laser SystemIpg Medical20240—
+7K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+7K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+7K230308Alma HarmonyAlma Lasers, Inc.20232—
+7K223680Eneka ProTermosalud20230—
+7K222701MANTA LaserSqualus Med, Ltd.20222—
+7K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+7K223132Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models)Iridex Corporation20221—
+7K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+7K222157ECHO PhotocoagulatorNorlase20220—
+7K222369PURE LaserEndymed Medical, Ltd.20220—
+7K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+7K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+7K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+7K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+7K210847UltraClear Fractional Laser SystemFa International, LP20210—
+7K203728DarwinLuvo Medical Technologies, Inc.20211—
+7K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+7K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+7K201623LION PhotocoagulatorNorlase Aps20201—
+7K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+7K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+7K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+7K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+7K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+7K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+7K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+7K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+7K171488PSLT for PASCAL StreamlineTopcon Medical Laser Systems, Inc.20171—
+7K170409PASCAL Synthesis Twinstar Ophthalmic Scanning Laser SystemTopcon Medical Laser Systems, Inc. (Tmls)20170—
+7K171227StarWalkerFotona D.O.O.20177—
+7K170067EasyretQuantel Medical20170—
+7K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+7K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+7K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+7K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+7K152714Quanta ForteQuanta System Spa201513—
+7K140120EPIC 10Biolase, Inc.20141—
+7K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+7K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—