510(k) Report

Devices descending from K990947

350 later devices reach Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K253680LYNX COBLATION Laryngeal Wand (72290254)ArthroCare Corporation20260—
+5K252971Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (Laser…C.R. Bard, Inc.20260—
+5K251996ENTire IRE SystemEntire Medical, Ltd.20261—
+5K251303Tamburo Thulium Fiber Laser SystemMenovex Medical Technology (Shenzhen) Co., Ltd.20250—
+5K251824Patriot DuoPatriot Laser, LLC20250—
+5K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+5K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+5K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+5K230914ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System…ArthroCare Corporation20230—
+5K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+5K221306SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed…Gyrus Acmi, Inc.202348
+5K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+5K212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc.20220—
+5K211517Optica XT Thulium Fiber Laser and Accessories, also known as Optica XT, Optica XT…Convergent Laser Technologies20210—
+5K211401SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser…Gyrus Acmi, Inc.202171
+5K192600Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60Quanta System Spa20205—
+5K192990Litho EvoQuanta System Spa20190—
+5K180922Empower H100, Cyber Ho 100, Litho 100Quanta System Spa20186—
+5K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+5K152744Diego Elite DrillGyrus Acmi, Inc.20160—
+5K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+5K151743THUNDERBEAT Open Fine JawOlympus Medical Systems Corp.20166—
+5K152702Ent Biotech Solutions Tissue Removal Device (Elasso)Ent Biotech Solutions20160—
+5K151629Guardian 1000Quanta System Spa20150—
+5K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+5K142289PK SpatulaGyrus Acmi, Inc.20141—
+5K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+5K133837Viora V-TotalViora, Ltd.201433—
+5K124033Medisiss Reprocessed Ultrasonic InstrumentsSurgical Instruments Service and Savings, Inc.20140—
+5K133314Harmonic Focus Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC20139—
+5K122493GenesisplusCutera, Inc.201318—
+5K123429Olympus Energy Power System (Eps)Gyrus Acmi, Inc.2013112
+5K121327Diolase 10SBiolase Technology, Inc.20132—
+5K113843Freedom ND: Yag Laser SystemLutronic Corporation20120—
+5K121678DTADGyrus Acmi, Inc.20122—
+5K111059Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill)Gyrus Acmi, Inc.20113—
+5K103775Peak Suction CoagulatorPeak Surgical, Inc.20111—
+5K102709Peak Plasmablade Plus Tissue Dissection DevicePeak Surgical, Inc.20100—
+5K091674Arthrocare Coblator IQ SystemArthrocare Corp.20101—
+5K080844G3 Generator and Accessories-Dissector Plasma KnifeGyrus Acmi, Inc.20091—
+5K083013PK Diego Powered Dissector Console, Model 7033-9050, Diego Trigger-Enabled Powered…Gyrus Acmi, Inc.20080—
+5K080093PKS Plasma Morcellator, Models 962000PK, 3620PKGyrus Acmi, Inc.20081—
+5K072302Entellus Medical RS-Series SystemEntellus Medical, Inc.200844—
+5K050550Gyrus General Purpose Electrosurgical GeneratorGyrus Medical, Inc.200514—
+5K050460Gyrus Plasmacision and Plasmablend ElectrodesGyrus Medical, Inc.20056—
+5K033257Arthrocare Ent Plasma WandsArthrocare Corp.200342—
+6K261202ENTire IRE SystemEntire Medical, Ltd.20260—
+6K252745Halo Sterile Single-use Radial Fiber…Micro-Energy Medical Technology Co., Ltd.20251—
+6K253007Laser 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—
+6K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+6K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+6K242251Litho 60; Litho 100; Litho 150Quanta System Spa20240—
+6K242191SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed…Olympus Surgical Technologies America202437
+6K233344Regenalase Laser SystemIpg Medical20240—
+6K232568IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and AccessoriesIpg Medical Corporation202411
+6K231054V-LaserWontech Co., Ltd.20231—
+6K223540AvalancheLase FamilyFotona D.O.O.20230—
+6K213831Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK NeedleGyrus Acmi, Inc.20220—
+6K211838Ultrasonic Bipolar Generator USG-410 with accessoriesOlympus Medical Systems Corporation2021313
+6K203788DermaV Laser SystemLutronic Corporation202101
+6K201455Litho 150, Cyber Ho 150Quanta System Spa20203—
+6K192103Thunderbeat Open Fine Jaw Type X Hand InstrumentOlympus Medical Systems Corp.20204—
+6K193656SkyPulseFotona D.O.O.202011—
+6K190610Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologySterilmed, Inc.20190—
+6K183156V-LaserWontech Co., Ltd.20193—
+6K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+6K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+6K181518Sebacia MicroparticlesSebacia, Inc.20180—
+6K171227StarWalkerFotona D.O.O.20177—
+6K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+6K170908PK AIMGyrus Acmi, Inc.20170—
+6K170456Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologyStryker Sustainability Solutions201701
+6K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+6K161038PK MorcellatorGyrus Acmi, Inc.20160—
+6K153371Sonicision Cordless Ultrasonic Dissection DeviceCovidien, LLC20164—
+6K150524Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue TechnologySurgical Instrument Services and Savings, Inc.20150—
+6K151340HARMONIC Focus Long Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC20150—
+6K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+6K142350PK J-HookGyrus Acmi, Inc.201511
+6K142525PK Lap LoopOlympus Winter & Ibe GmbH20140—
+6K142093V20 SystemViora, Ltd.201432—
+6K140122Candela Gentlemax Family of Laser SystemCandela Corp.201410—
+6K131839DC 7Dc International, LLC20130—
+6K131205Arthrocare Head and Neck Coblation WandArthroCare Corporation20130—
+6K130305Lina Bipolar Loop; Standard Size, Large Size, Extra Large SizeLina Medical Aps20130—
+6K130465EPIC 10SBiolase Technology, Inc.20130—
+6K122605PKS BillGyrus Acmi, Inc.20121—
+6K102366Finess EndoscopeEntellus Medical, Inc.20110—
+6K100896Gyrus Acmi Halo PKS Cutting ForcepsGyrus Acmi, Inc.201031
+6K081766PKS Omni InstrumentGyrus-Acmi L.P.200831
+6K081954Gyrus Acmi General Surgery Workstation, Model G400, and Dual Footswitch Connector CableGyrus Acmi, Inc.20080—
+6K071759LTC Vad System, Models #Vad.400 (Electrosurgical Generator); PCS-900 and PCC-900 (Hand…Live Tissue Connect, Inc.20080—
+6K081542Modification to Entellus Medical RS-Series SystemEntellus Medical, Inc.200842—
+6K063538Arthrocare Controller (System 2000 and 8000), Arthrocare Patient Cable, Foot Control…Arthrocare Corp.200640—
+6K052692Suretek Medical Reprocessed Electrosurgical ElectrodesSuretek Medical20060—
+7K261221SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed…Olympus Surgical Technologies America20261—
+7K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…Olympus Medical Systems Corp.20260—
+7K261701Hemolase 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—
+7K253951Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B)…Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.20260—
+7K252771Holmium Laser System (Potent HP90); Holmium Laser System (Potent HP100); Holmium Laser…Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.20250—