510(k) Report

Devices descending from K951910

480 later devices reach Odyssey HO:Yag Surgical Laser Systems & Accessories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K161771Medilas H Laser FibersDornier Medtech America, Inc.20160—
+4K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+4K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+4K142999EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma Wand with Integrated…ArthroCare Corporation201443
+4K142226Pilot Ultra Diode LaserCAO Group, Inc.20140—
+4K142225Pilot Elite Diode LaserCAO Group, Inc.20140—
+4K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+4K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+4K132976AdvatxAdvalight Aps20141—
+4K131805Inpulse LaserIncisive, Inc.20130—
+4K122652Arthrocare Turbinator WandArthroCare Corporation20133—
+4K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+4K130413Pinpointe FootlaserNuvolase, Inc.20130—
+4K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+4K121508Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-NFotona D.D.20121—
+4K120938The PL-1064 Laser SystemSheaumann Laser, Inc.201214—
+4K120235Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo…Aerolase Medical Lasers, LLC201233—
+4K113702Fotona XP ND: Yag Laser SystemFotona D.D.201265—
+4K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+4K110375Blueshine's Gold SeriesBlueshine Srl20124—
+4K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+4K111483Joule Clearsense Laser SystemSciton, Inc20110—
+4K103338CooltouchNew Star Lasers, Inc.201101
+4K110370Q-ClearLight Age, Inc.201135—
+4K103626Cutera Genesisplus Laser SystemCutera, Inc.2011121—
+4K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+4K100558Quanta Diode Laser SystemQuanta System Spa201068—
+4K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+4K100597Harmonic Focus ShearsEthicon Endo-Surgery, LLC201018—
+4K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+4K083415Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection DevicePeak Surgical, Inc.20098—
+4K091323Modified Intermedic Diode Laser 980NM System (Multidiode SST 200)Intermedic Arfran, SA20090—
+4K041633Gyrus Plasmacision Laparoscopic SpatulaGyrus Medical, Inc.20048—
+4K041285Gyrus G3 System (Generator, Assessories, Somnoplasty Electrodes and Plasmacision…Gyrus Medical, Ltd.2004202
+4K034004Diego RF Powered Dissector and Drill System ConsoleGyrus Ent LLC200450—
+4K030033Lumenis Family of Disposable Contact Tip Delivery DevicesLumenis, Ltd.20030—
+4K030108Arthrocare Ent Coblator Surgery SystemArthrocare Corp.2003921
+5K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+5K261964Echolaser X4Elesta S.P.A20260—
+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—
+5K254197Picasso Pro Diode Laser (002-00460)CAO Group, Inc.20260—
+5K251996ENTire IRE SystemEntire Medical, Ltd.20261—
+5K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+5K251303Tamburo Thulium Fiber Laser SystemMenovex Medical Technology (Shenzhen) Co., Ltd.20250—
+5K251824Patriot DuoPatriot Laser, LLC20250—
+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—
+5K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+5K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+5K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+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—
+5K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+5K230914ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System…ArthroCare Corporation20230—
+5K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+5K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+5K221306SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed…Gyrus Acmi, Inc.202348
+5K222701MANTA LaserSqualus Med, Ltd.20222—
+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—
+5K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+5K210183Waterlase iPLusBiolase, Inc.20220—
+5K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—
+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
+5K200693K2 MobileHulaser, Inc.20202—
+5K193486Epic 980Biolase, Inc.20202—
+5K193367elysion-proHigh Technology Products S.L.U20203—
+5K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+5K192600Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60Quanta System Spa20205—
+5K192990Litho EvoQuanta System Spa20190—
+5K181614Sterling Supreme Diode LaserCAO Group, Inc.20190—
+5K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+5K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+5K180508Joule SystemSciton, Inc20183—
+5K180922Empower H100, Cyber Ho 100, Litho 100Quanta System Spa20186—
+5K180044SIROLaser BlueDentsply Sirona201812—
+5K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+5K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+5K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+5K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+5K152744Diego Elite DrillGyrus Acmi, Inc.20160—
+5K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+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—
+5K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+5K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+5K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+5K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+5K151629Guardian 1000Quanta System Spa20150—
+5K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+5K141237Harmony LiteAlma, Inc.20154—
+5K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+5K142289PK SpatulaGyrus Acmi, Inc.20141—