510(k) Report

Devices descending from K963339

675 later devices reach Coherent Ultrapulse CO2 Surgical Lasers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K242191SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed…Olympus Surgical Technologies America202437
+8K233344Regenalase Laser SystemIpg Medical20240—
+8K240999Legend X Applicator VOPollogen, Ltd.20241—
+8K233849BTL-499BTL Industries, Inc.20240—
+8K233604BTL-785SBTL Industries, Inc.20243—
+8K232568IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and AccessoriesIpg Medical Corporation202411
+8K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+8K230837PlazMagikAgnes Medical Co., Ltd.20240—
+8K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+8K232223PlaDuo SystemShenB Co., Ltd.20230—
+8K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+8K22079410PLTentech Co., Ltd.20220—
+8K221427V-LaserWontech Co., Ltd.20222—
+8K212790XLase PlusBiotec Italia, Srl20220—
+8K212472AgeJetTriworks Group Srl20220—
+8K213831Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK NeedleGyrus Acmi, Inc.20220—
+8K211838Ultrasonic Bipolar Generator USG-410 with accessoriesOlympus Medical Systems Corporation2021313
+8K201455Litho 150, Cyber Ho 150Quanta System Spa20203—
+8K200736Stardust MedI.T.S. Group S.R.L.20200—
+8K200616E>EyeCE-Swin20200—
+8K200786Venus EpileveVenus Concept USA, Inc.20200—
+8K192103Thunderbeat Open Fine Jaw Type X Hand InstrumentOlympus Medical Systems Corp.20204—
+8K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+8K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+8K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+8K190610Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologySterilmed, Inc.20190—
+8K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+8K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+8K170908PK AIMGyrus Acmi, Inc.20170—
+8K170456Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologyStryker Sustainability Solutions201701
+8K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+8K161038PK MorcellatorGyrus Acmi, Inc.20160—
+8K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+8K153566Magma SystemFormatk Systems, Ltd.20162—
+8K153371Sonicision Cordless Ultrasonic Dissection DeviceCovidien, LLC20164—
+8K150524Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue TechnologySurgical Instrument Services and Savings, Inc.20150—
+8K151340HARMONIC Focus Long Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC20150—
+8K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+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—
+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—
+9K254185Potenza PrimeJeisys Medical Incorporated20260—
+9K2615891927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+9K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.20260—
+9K261221SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed…Olympus Surgical Technologies America20261—
+9K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…Olympus Medical Systems Corp.20260—
+9K253484Lutronic GeniusCynosure Lutronic Technology Corporation20260—
+9K261701Hemolase 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—
+9K253803MILAN SystemLumenis Be, Ltd.20260—
+9K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+9K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+9K253750BTL-785NEHBTL Industries, Inc.20260—
+9K253951Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B)…Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.20260—
+9K251435InbellaIgnite RF SystemInbella Medical, Inc.20260—
+9K251254Ignite RF SystemInMode, Ltd.20260—
+9K252771Holmium Laser System (Potent HP90); Holmium Laser System (Potent HP100); Holmium Laser…Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.20250—
+9K252367InbellaMulti SystemInbella Medical, Inc.20250—
+9K252150Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410)…Olympus Medical Systems Corporation202504
+9K251100Ipgtfl-02Ipg Medical Corporation20250—
+9K250504Leonardo DusterCeramoptec GmbH20250—
+9K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+9K242469RFMagik LiteAgnes Medical Co., Ltd.20252—
+9K250809Stellar M22Lumenis Be, Ltd.20250—
+9K242532BTL-785BNF-EBTL Industries, Inc.20241—
+9K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+9K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+9K233642InMode RF SystemInMode, Ltd.20244—
+9K231777Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories…Olympus Winter & Ibe GmbH202302
+9K222790F65 Laser SystemLumenis Be, Ltd.20233—
+9K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+9K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+9K200427Sonicision Cordless Ultrasonic DissectorCovidien, LLC20200—
+9K201111GentleMax Pro PlusCandela Corporation20203—
+9K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+9K200110SANDRO DualWontech Co., Ltd.20202—
+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—
+9K162781Magma SparkFormatk Systems, Ltd.20160—
+9K161825PK AIMGyrus Acmi, Inc.20162—
+9K152611V20 systemViora, Ltd.20164—
+9K150035V10 systemViora, Ltd.201531—
+9K142759PK Cutting Forceps for ESG-400 WorkstationGyrus Acmi, Inc.20152—
+9K102003Xpress Balloon DeviceEntellus Medical, Inc.201036—
+9K093007Entellus Medical Balloon DeviceEntellus Medical, Inc.201041—