510(k) Report

Devices descending from K902990

484 later devices reach Coherent Holmium:Yag Surgical Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+6K111059Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill)Gyrus Acmi, Inc.20113—
+6K103775Peak Suction CoagulatorPeak Surgical, Inc.20111—
+6K102709Peak Plasmablade Plus Tissue Dissection DevicePeak Surgical, Inc.20100—
+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—
+6K091674Arthrocare Coblator IQ SystemArthrocare Corp.20101—
+6K080844G3 Generator and Accessories-Dissector Plasma KnifeGyrus Acmi, Inc.20091—
+6K083013PK Diego Powered Dissector Console, Model 7033-9050, Diego Trigger-Enabled Powered…Gyrus Acmi, Inc.20080—
+6K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+6K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+6K080093PKS Plasma Morcellator, Models 962000PK, 3620PKGyrus Acmi, Inc.20081—
+6K072302Entellus Medical RS-Series SystemEntellus Medical, Inc.200844—
+6K050550Gyrus General Purpose Electrosurgical GeneratorGyrus Medical, Inc.200514—
+6K050460Gyrus Plasmacision and Plasmablend ElectrodesGyrus Medical, Inc.20056—
+6K033257Arthrocare Ent Plasma WandsArthrocare Corp.200342—
+7K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+7K261964Echolaser X4Elesta S.P.A20260—
+7K261202ENTire IRE SystemEntire Medical, Ltd.20260—
+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—
+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—
+7K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+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—
+7K242251Litho 60; Litho 100; Litho 150Quanta System Spa20240—
+7K242191SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed…Olympus Surgical Technologies America202437
+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—
+7K232568IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and AccessoriesIpg Medical Corporation202411
+7K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+7K231054V-LaserWontech Co., Ltd.20231—
+7K230308Alma HarmonyAlma Lasers, Inc.20232—
+7K223680Eneka ProTermosalud20230—
+7K223540AvalancheLase FamilyFotona D.O.O.20230—
+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—
+7K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+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—
+7K213831Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK NeedleGyrus Acmi, Inc.20220—
+7K210847UltraClear Fractional Laser SystemFa International, LP20210—
+7K211838Ultrasonic Bipolar Generator USG-410 with accessoriesOlympus Medical Systems Corporation2021313
+7K203728DarwinLuvo Medical Technologies, Inc.20211—
+7K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+7K203788DermaV Laser SystemLutronic Corporation202101
+7K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+7K201455Litho 150, Cyber Ho 150Quanta System Spa20203—
+7K192103Thunderbeat Open Fine Jaw Type X Hand InstrumentOlympus Medical Systems Corp.20204—
+7K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+7K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+7K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+7K190610Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologySterilmed, Inc.20190—
+7K183156V-LaserWontech Co., Ltd.20193—
+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—
+7K181518Sebacia MicroparticlesSebacia, Inc.20180—
+7K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+7K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+7K171227StarWalkerFotona D.O.O.20177—
+7K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+7K170908PK AIMGyrus Acmi, Inc.20170—
+7K170456Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologyStryker Sustainability Solutions201701
+7K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+7K161038PK MorcellatorGyrus Acmi, Inc.20160—
+7K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+7K153371Sonicision Cordless Ultrasonic Dissection DeviceCovidien, LLC20164—
+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—
+7K150524Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue TechnologySurgical Instrument Services and Savings, Inc.20150—
+7K151340HARMONIC Focus Long Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC20150—
+7K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+7K142350PK J-HookGyrus Acmi, Inc.201511
+7K142525PK Lap LoopOlympus Winter & Ibe GmbH20140—
+7K142093V20 SystemViora, Ltd.201432—
+7K140120EPIC 10Biolase, Inc.20141—
+7K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+7K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+7K140122Candela Gentlemax Family of Laser SystemCandela Corp.201410—
+7K131839DC 7Dc International, LLC20130—
+7K131205Arthrocare Head and Neck Coblation WandArthroCare Corporation20130—
+7K130305Lina Bipolar Loop; Standard Size, Large Size, Extra Large SizeLina Medical Aps20130—
+7K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+7K130465EPIC 10SBiolase Technology, Inc.20130—
+7K122605PKS BillGyrus Acmi, Inc.20121—
+7K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+7K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+7K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—