510(k) Report

Devices descending from K960521

677 later devices reach Sharplan Lasers, Inc. Silktouch Flash Scanner through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K124033Medisiss Reprocessed Ultrasonic InstrumentsSurgical Instruments Service and Savings, Inc.20140—
+8K133314Harmonic Focus Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC20139—
+8K122493GenesisplusCutera, Inc.201318—
+8K123429Olympus Energy Power System (Eps)Gyrus Acmi, Inc.2013112
+8K121327Diolase 10SBiolase Technology, Inc.20132—
+8K113843Freedom ND: Yag Laser SystemLutronic Corporation20120—
+8K121678DTADGyrus Acmi, Inc.20122—
+8K111059Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill)Gyrus Acmi, Inc.20113—
+8K103775Peak Suction CoagulatorPeak Surgical, Inc.20111—
+8K102709Peak Plasmablade Plus Tissue Dissection DevicePeak Surgical, Inc.20100—
+8K091674Arthrocare Coblator IQ SystemArthrocare Corp.20101—
+8K080844G3 Generator and Accessories-Dissector Plasma KnifeGyrus Acmi, Inc.20091—
+8K083013PK Diego Powered Dissector Console, Model 7033-9050, Diego Trigger-Enabled Powered…Gyrus Acmi, Inc.20080—
+8K080093PKS Plasma Morcellator, Models 962000PK, 3620PKGyrus Acmi, Inc.20081—
+8K072302Entellus Medical RS-Series SystemEntellus Medical, Inc.200844—
+8K050550Gyrus General Purpose Electrosurgical GeneratorGyrus Medical, Inc.200514—
+8K050460Gyrus Plasmacision and Plasmablend ElectrodesGyrus Medical, Inc.20056—
+8K033257Arthrocare Ent Plasma WandsArthrocare Corp.200342—
+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—
+9K253484Lutronic GeniusCynosure Lutronic Technology Corporation20260—
+9K253803MILAN SystemLumenis Be, Ltd.20260—
+9K261202ENTire IRE SystemEntire Medical, 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—
+9K251435InbellaIgnite RF SystemInbella Medical, Inc.20260—
+9K251254Ignite RF SystemInMode, Ltd.20260—
+9K252745Halo Sterile Single-use Radial Fiber…Micro-Energy Medical Technology Co., Ltd.20251—
+9K253007Laser 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—
+9K252367InbellaMulti SystemInbella Medical, Inc.20250—
+9K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+9K242469RFMagik LiteAgnes Medical Co., Ltd.20252—
+9K250809Stellar M22Lumenis Be, Ltd.20250—
+9K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+9K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+9K242532BTL-785BNF-EBTL Industries, Inc.20241—
+9K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+9K242251Litho 60; Litho 100; Litho 150Quanta System Spa20240—
+9K242191SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed…Olympus Surgical Technologies America202437
+9K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+9K233344Regenalase Laser SystemIpg Medical20240—
+9K232568IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and AccessoriesIpg Medical Corporation202411
+9K233642InMode RF SystemInMode, Ltd.20244—
+9K222790F65 Laser SystemLumenis Be, Ltd.20233—
+9K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+9K213831Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK NeedleGyrus Acmi, Inc.20220—
+9K211838Ultrasonic Bipolar Generator USG-410 with accessoriesOlympus Medical Systems Corporation2021313
+9K201455Litho 150, Cyber Ho 150Quanta System Spa20203—
+9K192103Thunderbeat Open Fine Jaw Type X Hand InstrumentOlympus Medical Systems Corp.20204—
+9K190610Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologySterilmed, Inc.20190—
+9K170908PK AIMGyrus Acmi, Inc.20170—
+9K170456Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologyStryker Sustainability Solutions201701
+9K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+9K162781Magma SparkFormatk Systems, Ltd.20160—
+9K161038PK MorcellatorGyrus Acmi, Inc.20160—
+9K153371Sonicision Cordless Ultrasonic Dissection DeviceCovidien, LLC20164—
+9K150524Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue TechnologySurgical Instrument Services and Savings, Inc.20150—
+9K151340HARMONIC Focus Long Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC20150—
+9K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+9K142350PK J-HookGyrus Acmi, Inc.201511
+9K142525PK Lap LoopOlympus Winter & Ibe GmbH20140—
+9K142093V20 SystemViora, Ltd.201432—
+9K140122Candela Gentlemax Family of Laser SystemCandela Corp.201410—
+9K131839DC 7Dc International, LLC20130—
+9K131205Arthrocare Head and Neck Coblation WandArthroCare Corporation20130—
+9K130305Lina Bipolar Loop; Standard Size, Large Size, Extra Large SizeLina Medical Aps20130—
+9K130465EPIC 10SBiolase Technology, Inc.20130—
+9K122605PKS BillGyrus Acmi, Inc.20121—
+9K102366Finess EndoscopeEntellus Medical, Inc.20110—
+9K100896Gyrus Acmi Halo PKS Cutting ForcepsGyrus Acmi, Inc.201031
+9K081766PKS Omni InstrumentGyrus-Acmi L.P.200831
+9K081954Gyrus Acmi General Surgery Workstation, Model G400, and Dual Footswitch Connector CableGyrus Acmi, Inc.20080—
+9K071759LTC Vad System, Models #Vad.400 (Electrosurgical Generator); PCS-900 and PCC-900 (Hand…Live Tissue Connect, Inc.20080—
+9K081542Modification to Entellus Medical RS-Series SystemEntellus Medical, Inc.200842—
+9K063538Arthrocare Controller (System 2000 and 8000), Arthrocare Patient Cable, Foot Control…Arthrocare Corp.200640—
+9K052692Suretek Medical Reprocessed Electrosurgical ElectrodesSuretek Medical20060—
+10K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—
+10K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+10K261221SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed…Olympus Surgical Technologies America20261—
+10K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…Olympus Medical Systems Corp.20260—
+10K261701Hemolase 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—
+10K253951Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B)…Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.20260—
+10K252771Holmium Laser System (Potent HP90); Holmium Laser System (Potent HP100); Holmium Laser…Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.20250—
+10K252150Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410)…Olympus Medical Systems Corporation202504
+10K251100Ipgtfl-02Ipg Medical Corporation20250—
+10K250217AGNES UltraAgnes Medical Co., Ltd.20250—
+10K243713Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A…Agnes Medical Co., Ltd.20250—
+10K250504Leonardo DusterCeramoptec GmbH20250—
+10K242349FoLixLumenis Be, Ltd.20240—
+10K240780InMode RF SystemInMode, Ltd.20243—
+10K231777Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories…Olympus Winter & Ibe GmbH202302
+10K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+10K200427Sonicision Cordless Ultrasonic DissectorCovidien, LLC20200—
+10K201111GentleMax Pro PlusCandela Corporation20203—
+10K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+10K200110SANDRO DualWontech Co., Ltd.20202—
+10K183452Vbeam Prima Laser SystemCandela Corp.20191—
+10K173627Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorSurgical Instrument Service and Savings, Inc.20180—