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
+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—
+6K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+6K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+6K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+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—
+7K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+7K261221SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed…Olympus Surgical Technologies America20261—
+7K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+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—
+7K260138LUNE PureHygieneEnamel Pure20260—
+7K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+7K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+7K253951Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B)…Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.20260—
+7K252561BTL-754FFBTL Industries, Inc.20260—
+7K251730LIA Console (542-7)Leadoptik, Inc.20250—
+7K252771Holmium Laser System (Potent HP90); Holmium Laser System (Potent HP100); Holmium Laser…Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.20250—
+7K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+7K252150Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410)…Olympus Medical Systems Corporation202504
+7K242859VEGAIbramed Equipamentos Médicos20250—
+7K251100Ipgtfl-02Ipg Medical Corporation20250—
+7K250504Leonardo DusterCeramoptec GmbH20250—
+7K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+7K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+7K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE…Gigaalaser Company, Ltd.20251—
+7K251094Alma VeilWontech Co., Ltd.20250—
+7K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+7K241656Eneka SelectifTermosalud20241—
+7K241600DermablateAsclepion Laser Technologies GmbH20240—
+7K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+7K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+7K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+7K234057NirvanaEl.En S.P.A.20240—
+7K233024Alma HarmonyAlma Lasers, Inc.20241—
+7K232236EchoQuanta System Spa20230—
+7K231777Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories…Olympus Winter & Ibe GmbH202302
+7K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+7K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+7K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+7K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+7K213267Dynamis Pro FamilyFotona D.O.O.20222—
+7K221427V-LaserWontech Co., Ltd.20222—
+7K221571InMode Multi-systemInMode, Ltd.20222—
+7K213350mJOULE System and AccessoriesSciton, Inc20220—
+7K202288FinebeamSNJ Co., Ltd.20212—
+7K212607DarwinLuvo Medical Technologies, Inc.20210—
+7K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+7K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+7K202172StarWalkerFotona D.O.O.20203—
+7K202041Opera EvoQuanta System Spa20200—
+7K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+7K200427Sonicision Cordless Ultrasonic DissectorCovidien, LLC20200—
+7K201111GentleMax Pro PlusCandela Corporation20203—
+7K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+7K192856MT OneM&T S.R.L.20202—
+7K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+7K200110SANDRO DualWontech Co., Ltd.20202—
+7K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+7K191942MT One DiamondM&T S.R.L.20191—
+7K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+7K183452Vbeam Prima Laser SystemCandela Corp.20191—
+7K173627Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorSurgical Instrument Service and Savings, Inc.20180—
+7K180149Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw…Covidien, LLC201812
+7K172413MT ONEM&T S.R.L.20175—
+7K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+7K161825PK AIMGyrus Acmi, Inc.20162—
+7K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+7K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+7K152611V20 systemViora, Ltd.20164—
+7K150035V10 systemViora, Ltd.201531—
+7K142759PK Cutting Forceps for ESG-400 WorkstationGyrus Acmi, Inc.20152—
+7K102003Xpress Balloon DeviceEntellus Medical, Inc.201036—
+7K093007Entellus Medical Balloon DeviceEntellus Medical, Inc.201041—
+8K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+8K252723Dynamis Pro FamilyFotona D.O.O.20260—
+8K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+8K262877SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed…Olympus Surgical Technologies America20260—
+8K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+8K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight…Wuhan PHOMED Technology Company, Ltd.20260—
+8K253828Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+8K253342PICO-KSpeclipse, Inc.20251—
+8K252877SANDRO DualWontech Co., Ltd.20250—
+8K253344Bellus-QSpeclipse, Inc.20250—
+8K251632Optimas MAX SystemInMode, Ltd.20251—
+8K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+8K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System…Beijing Adss Development Co., Ltd.20241—