510(k) Report

Devices descending from K871179

323 later devices reach Opn Xii UL through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K982636Patient Warmer- Model PW810Fisher & Paykel Healthcare, Ltd.1998322—
+2K030489BRM2 Brain MonitorBrainz Instruments, Ltd.200325—
+2K022609Surgical Patient Warmer, Model PW820 JhuFisher & Paykel Healthcare, Ltd.2003295—
+3K072382Model I-2000 MonitorInfinite Biomedical Technologies200812—
+3K071449BRM3 Brain MonitorBrainz Instruments, Ltd.200715—
+3K033768Altus Medical Optional Infrared HandpieceAltus Medical, Inc.2004294—
+3K033010BRM2 Brain MonitorBrainz Instruments, Ltd.200323—
+4K092477NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701Neurowave Systems, Inc.20106—
+4K082886Zoom-100DCBrainscope Company, Inc.200911—
+4K081551Twin Neurotrac-IiiAstro-Med, Inc.20088—
+4K080217Component Neuromonitoring SystemMoberg Research, Inc.2008141
+4K080318Alma Laser Nir ModuleAlma Lasers, Ltd.2008184—
+4K050370Palomar Luxir HandpiecePalomar Medical Technologies, Inc.2005239—
+4K041885Bioflex LD-175 and LD-1200 Treatment HeadsMeditech International, Inc.20052—
+4K042165Cutera Tabletop Aesthetic ProductCutera, Inc.20042411
+5K200878Natus NeuroWorksNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)20201—
+5K191868iCEWav Neuromonitoring PlatformIce Neurosystems, Inc.20200—
+5K192572CNS EnvisionMoberg Research, Inc.20190—
+5K173366NicoletOneNatus Neurology Incorporated20183—
+5K142834DiscoverEEG System, Model DE-401Neurowave Systems, Inc.20155—
+5K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+5K131944IEEGJordan Neuroscience, Inc.20140—
+5K120485Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend and FFT PNihon Kohden America, Inc.20125—
+5K101916Joule Multi-Platform SystemSciton, Inc2011111—
+5K102716Modified Alma Lasers Family of Soprano XL Multi-Application PlatmformsAlma Lasers, Inc.2010124—
+5K092573Nihon Kohden QP-160AK Eeg Trend ProgramNihon Kohden America, Inc.20107—
+5K083595EzlaseBiolase Technology, Inc.200958—
+5K081355Bioflex LD-R100 Treatment HeadMeditech International, Inc.20080—
+5K070298Modification to Palomar Luxir HandpiecePalomar Medical Technologies, Inc.200764—
+5K070388Profile Multi-Platform SystemSciton, Inc2007129—
+5K051875Bioflex Prescription System and Related Treatment HeadsMeditech International, Inc.20061—
+5K052647Clini-Lase System, Models CL-Base, CL-2000, CL-1200, CL-500, CL-300, CL-275, CL-155…American Spine Center, Ltd.20052—
+5K050069Cutera Flashlamp Tabletop Aesthetic ProductCutera, Inc.20050—
+6K251881HippoMind (v1.0)Hippoclinic20250—
+6K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+6K213761Joule diVa SystemSciton, Inc20220—
+6K213299Wireless EEG SystemPascall Systems, Inc.20222—
+6K192549Byteflies KitByteflies NV20201—
+6K193656SkyPulseFotona D.O.O.202011—
+6K193367elysion-proHigh Technology Products S.L.U20203—
+6K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+6K190760Cadwell Bolt SoftwareCadwell Industries, Inc.20190—
+6K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+6K173285Joule SystemSciton, Inc20185—
+6K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+6K163644Nihon Kohden QP-160AK EEG Trend ProgramNihon Kohden Corporation20170—
+6K152301Background Pattern Classification [BPc (TM)]Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)20160—
+6K141237Harmony LiteAlma, Inc.20154—
+6K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+6K130238Nihon Kohden AE-918P Neuro UnitNihon Kohden Corp.20150—
+6K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+6K132976AdvatxAdvalight Aps20141—
+6K132989Speed 808 Diode Laser SystemBeijing Toplaser Technology Co., Ltd.20140—
+6K123971Cynosure 1064NM Diode LaserCynosure, Inc.201325—
+6K123257Emvera DioluxEmvera Technologies, Inc.20123—
+6K121286EPIC 10Biolase Technology, Inc.201231—
+6K112031Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for Use with the Family…Alma Lasers, Inc.2011118—
+6K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+6K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+6K101573Accusculpt II Laser SystemLutronic Corporation20101—
+6K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+6K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+6K081352Profile Multi-Platform SystemSciton, Inc2008112—
+6K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+6K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+6K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+6K060134Apollo IR Heat Lamp SystemApollo Physical Therapy Products International200611
+7K254213Pascall Sensor Unit (PSU1)Pascall Systems, Inc.20260—
+7K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+7K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+7K251550NX01 (NX01)Naox Technologies Sas20250—
+7K250189AdvaTxAdvalight Aps20250—
+7K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+7K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+7K240593VEEGix EEG SystemNeuroServo, Inc.20240—
+7K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+7K233473Deka LotusEl.En S.P.A.20241—
+7K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+7K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+7K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+7K230308Alma HarmonyAlma Lasers, Inc.20232—
+7K223680Eneka ProTermosalud20230—
+7K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+7K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+7K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+7K222369PURE LaserEndymed Medical, Ltd.20220—
+7K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+7K210183Waterlase iPLusBiolase, Inc.20220—
+7K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+7K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+7K203728DarwinLuvo Medical Technologies, Inc.20211—
+7K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+7K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+7K192856MT OneM&T S.R.L.20202—
+7K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+7K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+7K192430Epic 980Biolase, Inc.20195—
+7K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+7K181019Diode Laser SystemGuangzhou Huafei Tongda Technology Co., Ltd.20186—
+7K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—