510(k) Report

Devices descending from K960413

483 later devices reach Coherent Slimline Single Lumen Aspiration Needle Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K253633Holmium Laser Therapeutic Apparatus (HZ-40)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.20260—
+5K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+5K252529Moses™ 200 D/F/L Laser Fiber (M0068130100); Moses™ 365 D/F/L Laser Fiber (M0068130110)…Boston Scientific Corporation20250—
+5K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+5K251759Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser…Boston Scientific Corporation20250—
+5K250189AdvaTxAdvalight Aps20250—
+5K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+5K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+5K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+5K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+5K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+5K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+5K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+5K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+5K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+5K231718Holmium Medical LaserAllengers Global Healthcare Private Limited20230—
+5K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+5K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+5K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+5K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+5K213252Dornier ThulioDornier Medtech America, Inc.20220—
+5K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+5K210183Waterlase iPLusBiolase, Inc.20220—
+5K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+5K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+5K202702FLARE Single-Use Surgical Laser FiberRealton (Suzhou) Medical Technology Co., Ltd.20210—
+5K202006ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter…ArthroCare Corporation20202—
+5K193367elysion-proHigh Technology Products S.L.U20203—
+5K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+5K192027WEREWOLF COBLATION System, COBLATION HALO WandArthroCare Corporation20193—
+5K183647SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed…Olympus Surgical Technologies America2019124
+5K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+5K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc.20190—
+5K180508Joule SystemSciton, Inc20183—
+5K180426Empower H35Quanta System Spa20181—
+5K180350Dornier Medilas H Solvo 35 LaserDornier Medtech America20180—
+5K172647Reprocessed ArthroCare ENT CoblatorRenovo, Inc.20180—
+5K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+5K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+5K172025Litho 60Quanta System Spa20178—
+5K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+5K161771Medilas H Laser FibersDornier Medtech America, Inc.20160—
+5K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+5K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+5K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+5K141237Harmony LiteAlma, Inc.20154—
+5K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+5K142999EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma Wand with Integrated…ArthroCare Corporation201443
+5K133774AtovenBio-Med USA, Inc.20146—
+5K131805Inpulse LaserIncisive, Inc.20130—
+5K122652Arthrocare Turbinator WandArthroCare Corporation20133—
+5K130413Pinpointe FootlaserNuvolase, Inc.20130—
+5K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+5K121508Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-NFotona D.D.20121—
+5K120938The PL-1064 Laser SystemSheaumann Laser, Inc.201214—
+5K120235Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo…Aerolase Medical Lasers, LLC201233—
+5K113702Fotona XP ND: Yag Laser SystemFotona D.D.201265—
+5K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+5K110375Blueshine's Gold SeriesBlueshine Srl20124—
+5K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+5K111483Joule Clearsense Laser SystemSciton, Inc20110—
+5K103338CooltouchNew Star Lasers, Inc.201101
+5K110370Q-ClearLight Age, Inc.201135—
+5K103626Cutera Genesisplus Laser SystemCutera, Inc.2011121—
+5K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+5K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+5K100558Quanta Diode Laser SystemQuanta System Spa201068—
+5K100597Harmonic Focus ShearsEthicon Endo-Surgery, LLC201018—
+5K083415Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection DevicePeak Surgical, Inc.20098—
+5K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+5K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+5K041633Gyrus Plasmacision Laparoscopic SpatulaGyrus Medical, Inc.20048—
+5K041285Gyrus G3 System (Generator, Assessories, Somnoplasty Electrodes and Plasmacision…Gyrus Medical, Ltd.2004202
+5K034004Diego RF Powered Dissector and Drill System ConsoleGyrus Ent LLC200450—
+5K030033Lumenis Family of Disposable Contact Tip Delivery DevicesLumenis, Ltd.20030—
+5K030108Arthrocare Ent Coblator Surgery SystemArthrocare Corp.2003921
+5K022475Modification to Arthrocare Controller (System 2000 and 8000), Arthrocare Patient Cable…Arthrocare Corp.20020—
+6K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+6K261964Echolaser X4Elesta S.P.A20260—
+6K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+6K253680LYNX COBLATION Laryngeal Wand (72290254)ArthroCare Corporation20260—
+6K252971Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (Laser…C.R. Bard, Inc.20260—
+6K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+6K251996ENTire IRE SystemEntire Medical, Ltd.20261—
+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—
+6K251303Tamburo Thulium Fiber Laser SystemMenovex Medical Technology (Shenzhen) Co., Ltd.20250—
+6K251824Patriot DuoPatriot Laser, LLC20250—
+6K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+6K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+6K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+6K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+6K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+6K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+6K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+6K233344Regenalase Laser SystemIpg Medical20240—
+6K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+6K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+6K230914ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System…ArthroCare Corporation20230—
+6K230308Alma HarmonyAlma Lasers, Inc.20232—