510(k) Report

Devices descending from K913136

484 later devices reach Laser Endoscope Disc Decompression Kits through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K230308Alma HarmonyAlma Lasers, Inc.20232—
+7K223680Eneka ProTermosalud20230—
+7K221306SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed…Gyrus Acmi, Inc.202348
+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—
+7K212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc.20220—
+7K210847UltraClear Fractional Laser SystemFa International, LP20210—
+7K211517Optica XT Thulium Fiber Laser and Accessories, also known as Optica XT, Optica XT…Convergent Laser Technologies20210—
+7K203728DarwinLuvo Medical Technologies, Inc.20211—
+7K211401SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser…Gyrus Acmi, Inc.202171
+7K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+7K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+7K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+7K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+7K192600Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60Quanta System Spa20205—
+7K192990Litho EvoQuanta System Spa20190—
+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—
+7K180922Empower H100, Cyber Ho 100, Litho 100Quanta System Spa20186—
+7K171227StarWalkerFotona D.O.O.20177—
+7K152744Diego Elite DrillGyrus Acmi, Inc.20160—
+7K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+7K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+7K151743THUNDERBEAT Open Fine JawOlympus Medical Systems Corp.20166—
+7K152702Ent Biotech Solutions Tissue Removal Device (Elasso)Ent Biotech Solutions20160—
+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—
+7K151629Guardian 1000Quanta System Spa20150—
+7K142289PK SpatulaGyrus Acmi, Inc.20141—
+7K140120EPIC 10Biolase, Inc.20141—
+7K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+7K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+7K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+7K133837Viora V-TotalViora, Ltd.201433—
+7K124033Medisiss Reprocessed Ultrasonic InstrumentsSurgical Instruments Service and Savings, Inc.20140—
+7K133314Harmonic Focus Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC20139—
+7K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+7K122493GenesisplusCutera, Inc.201318—
+7K123429Olympus Energy Power System (Eps)Gyrus Acmi, Inc.2013112
+7K121327Diolase 10SBiolase Technology, Inc.20132—
+7K113843Freedom ND: Yag Laser SystemLutronic Corporation20120—
+7K121678DTADGyrus Acmi, Inc.20122—
+7K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+7K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+7K111059Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill)Gyrus Acmi, Inc.20113—
+7K103775Peak Suction CoagulatorPeak Surgical, Inc.20111—
+7K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+7K102709Peak Plasmablade Plus Tissue Dissection DevicePeak Surgical, Inc.20100—
+7K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+7K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+7K091674Arthrocare Coblator IQ SystemArthrocare Corp.20101—
+7K080844G3 Generator and Accessories-Dissector Plasma KnifeGyrus Acmi, Inc.20091—
+7K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+7K083013PK Diego Powered Dissector Console, Model 7033-9050, Diego Trigger-Enabled Powered…Gyrus Acmi, Inc.20080—
+7K080093PKS Plasma Morcellator, Models 962000PK, 3620PKGyrus Acmi, Inc.20081—
+7K072302Entellus Medical RS-Series SystemEntellus Medical, Inc.200844—
+7K050550Gyrus General Purpose Electrosurgical GeneratorGyrus Medical, Inc.200514—
+7K050460Gyrus Plasmacision and Plasmablend ElectrodesGyrus Medical, Inc.20056—
+7K033257Arthrocare Ent Plasma WandsArthrocare Corp.200342—
+8K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+8K261701Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)Micro-Energy Medical Technology Co., Ltd.20260—
+8K261202ENTire IRE SystemEntire Medical, Ltd.20260—
+8K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+8K252561BTL-754FFBTL Industries, Inc.20260—
+8K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+8K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+8K242859VEGAIbramed Equipamentos Médicos20250—
+8K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+8K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+8K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+8K242251Litho 60; Litho 100; Litho 150Quanta System Spa20240—
+8K242191SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed…Olympus Surgical Technologies America202437
+8K241656Eneka SelectifTermosalud20241—
+8K241600DermablateAsclepion Laser Technologies GmbH20240—
+8K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+8K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+8K234057NirvanaEl.En S.P.A.20240—
+8K232568IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and AccessoriesIpg Medical Corporation202411
+8K233024Alma HarmonyAlma Lasers, Inc.20241—
+8K232236EchoQuanta System Spa20230—
+8K231054V-LaserWontech Co., Ltd.20231—
+8K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+8K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+8K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+8K223540AvalancheLase FamilyFotona D.O.O.20230—
+8K213267Dynamis Pro FamilyFotona D.O.O.20222—
+8K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+8K221571InMode Multi-systemInMode, Ltd.20222—
+8K213350mJOULE System and AccessoriesSciton, Inc20220—