510(k) Report

Devices descending from K913136

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K213831Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK NeedleGyrus Acmi, Inc.20220—
+8K202288FinebeamSNJ Co., Ltd.20212—
+8K212607DarwinLuvo Medical Technologies, Inc.20210—
+8K211838Ultrasonic Bipolar Generator USG-410 with accessoriesOlympus Medical Systems Corporation2021313
+8K203788DermaV Laser SystemLutronic Corporation202101
+8K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+8K202172StarWalkerFotona D.O.O.20203—
+8K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+8K201455Litho 150, Cyber Ho 150Quanta System Spa20203—
+8K192103Thunderbeat Open Fine Jaw Type X Hand InstrumentOlympus Medical Systems Corp.20204—
+8K192856MT OneM&T S.R.L.20202—
+8K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+8K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+8K191942MT One DiamondM&T S.R.L.20191—
+8K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+8K190610Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologySterilmed, Inc.20190—
+8K183156V-LaserWontech Co., Ltd.20193—
+8K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+8K181518Sebacia MicroparticlesSebacia, Inc.20180—
+8K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+8K172413MT ONEM&T S.R.L.20175—
+8K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+8K170908PK AIMGyrus Acmi, Inc.20170—
+8K170456Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologyStryker Sustainability Solutions201701
+8K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+8K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+8K161038PK MorcellatorGyrus Acmi, Inc.20160—
+8K161185LUCERNA Dental LaserViax Dental Lab20160—
+8K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+8K153371Sonicision Cordless Ultrasonic Dissection DeviceCovidien, LLC20164—
+8K150524Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue TechnologySurgical Instrument Services and Savings, Inc.20150—
+8K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+8K151340HARMONIC Focus Long Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC20150—
+8K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+8K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+8K142350PK J-HookGyrus Acmi, Inc.201511
+8K142525PK Lap LoopOlympus Winter & Ibe GmbH20140—
+8K142093V20 SystemViora, Ltd.201432—
+8K140122Candela Gentlemax Family of Laser SystemCandela Corp.201410—
+8K131839DC 7Dc International, LLC20130—
+8K131205Arthrocare Head and Neck Coblation WandArthroCare Corporation20130—
+8K130305Lina Bipolar Loop; Standard Size, Large Size, Extra Large SizeLina Medical Aps20130—
+8K130465EPIC 10SBiolase Technology, Inc.20130—
+8K122605PKS BillGyrus Acmi, Inc.20121—
+8K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+8K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+8K102366Finess EndoscopeEntellus Medical, Inc.20110—
+8K100896Gyrus Acmi Halo PKS Cutting ForcepsGyrus Acmi, Inc.201031
+8K081766PKS Omni InstrumentGyrus-Acmi L.P.200831
+8K081954Gyrus Acmi General Surgery Workstation, Model G400, and Dual Footswitch Connector CableGyrus Acmi, Inc.20080—
+8K071759LTC Vad System, Models #Vad.400 (Electrosurgical Generator); PCS-900 and PCC-900 (Hand…Live Tissue Connect, Inc.20080—
+8K081542Modification to Entellus Medical RS-Series SystemEntellus Medical, Inc.200842—
+8K063538Arthrocare Controller (System 2000 and 8000), Arthrocare Patient Cable, Foot Control…Arthrocare Corp.200640—
+8K052692Suretek Medical Reprocessed Electrosurgical ElectrodesSuretek Medical20060—
+9K252723Dynamis Pro FamilyFotona D.O.O.20260—
+9K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+9K261221SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed…Olympus Surgical Technologies America20261—
+9K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+9K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…Olympus Medical Systems Corp.20260—
+9K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+9K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+9K253951Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B)…Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.20260—
+9K253342PICO-KSpeclipse, Inc.20251—
+9K251730LIA Console (542-7)Leadoptik, Inc.20250—
+9K253344Bellus-QSpeclipse, Inc.20250—
+9K252771Holmium Laser System (Potent HP90); Holmium Laser System (Potent HP100); Holmium Laser…Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.20250—
+9K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+9K252150Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410)…Olympus Medical Systems Corporation202504
+9K251100Ipgtfl-02Ipg Medical Corporation20250—
+9K250504Leonardo DusterCeramoptec GmbH20250—
+9K251632Optimas MAX SystemInMode, Ltd.20251—
+9K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+9K251094Alma VeilWontech Co., Ltd.20250—
+9K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+9K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+9K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+9K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+9K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+9K231777Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories…Olympus Winter & Ibe GmbH202302
+9K22079410PLTentech Co., Ltd.20220—
+9K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+9K221427V-LaserWontech Co., Ltd.20222—
+9K212790XLase PlusBiotec Italia, Srl20220—
+9K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+9K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+9K202041Opera EvoQuanta System Spa20200—
+9K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+9K200427Sonicision Cordless Ultrasonic DissectorCovidien, LLC20200—
+9K200736Stardust MedI.T.S. Group S.R.L.20200—
+9K200616E>EyeCE-Swin20200—
+9K201111GentleMax Pro PlusCandela Corporation20203—
+9K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+9K200110SANDRO DualWontech Co., Ltd.20202—
+9K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+9K183452Vbeam Prima Laser SystemCandela Corp.20191—
+9K173627Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorSurgical Instrument Service and Savings, Inc.20180—
+9K180149Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw…Covidien, LLC201812
+9K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+9K161825PK AIMGyrus Acmi, Inc.20162—
+9K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—