510(k) Report

Devices descending from K952681

1,700 later devices reach Stryker Hummer II Microdebrider System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+7K120280Relieva Seeker Balloon Sinuplasty SystemAcclarent, Inc.20122—
+7K121351Sinus Dilation SystemEntrigue Surgical, Inc.20128—
+7K120513Glow by EndymedEndymed Medical, Ltd.20125—
+7K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+7K111670Venus Freeze (MP)2 SystemVenus Concept, Ltd.201213—
+7K111286Quasar CalypsoSilver Bay, LLC201276—
+7K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+7K112506Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201121—
+7K111026ApolloPollogen, Ltd.201114—
+7K111875Relieva Spin Sinus Dilation SystemAcclarent, Inc.20117—
+7K111784Venus Swan SystemVenus Concept, Ltd.20111—
+7K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+7K111254Relieva Solo Elite Sinus Balloon CatheterAcclarent, Inc.20117—
+7K110301Silk'n FXHome Skinovations, Ltd.201166—
+7K110158Illuminating Sinus SeekerEntellus Medical, Inc.20113—
+7K102461FractoraInvasix, Ltd.201124—
+7K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+7K102698Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model Pelleve GlidesafeEllman Int'L, Inc.201139—
+7K103415Tanda MaxPharos Life Corporation20110—
+7K100628PlasmaluxlsDaavlin Distributing Co.20100—
+7K101573Accusculpt II Laser SystemLutronic Corporation20101—
+7K091467Baby QuasarSilver Bay, LLC20100—
+7K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+7K102368Non-Ablative Wrinkle Treatment HandpieceEllman Int'L, Inc.201052—
+7K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+7K090744CLAROClrs Technology Corporation20101—
+7K092460Star-Lite -LM, Model SL8809Ps Advanced Engineering20101—
+7K092800Anti-Wrinkle (Aging) Light, Model AalLed Intellectual Properties, LLC201011—
+7K093465Fusion SystemEclipsemed Global, Inc.20100—
+7K092195Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc.20090—
+7K083183Aklarus Phototherapy SystemHill Laboratories Co.200991—
+7K090221Reaction SystemViora, Ltd.200954—
+7K091323Modified Intermedic Diode Laser 980NM System (Multidiode SST 200)Intermedic Arfran, SA20090—
+7K090525Loi SystemPalomar Medical Products, Inc.20099—
+7K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+7K083733Lume 2 System, Model GA0005000Lumenis, Ltd.200939—
+7K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+7K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+7K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+7K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+7K081352Profile Multi-Platform SystemSciton, Inc2008112—
+7K081408Ellipse MultiflexEllipse A/S20087—
+7K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+7K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+7K080118Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics200833—
+7K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+7K080300Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc.2008101—
+7K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+7K073111Portrait PSR, Model 745915Rhytec Incorporated20084—
+7K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa2007263—
+7K072394Portrait Stand-OffRhytec Incorporated2007104—
+7K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc.2007229—
+7K071872VelashapeSyneron Medical, Ltd.2007127—
+7K070092Modification to Velasmooth, ShaperSyneron Medical, Ltd.2007128—
+7K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc.2007230—
+7K063396Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L.200722—
+7K061603SmoothshapesBiocellulase, Inc.200648—
+7K053611SmoothshapesBicellulase, Inc.200695—
+7K053616Polaris WR, ST ApplicatorSyneron Medical, Ltd.2006133—
+7K052324Polaris LV, Lva ApplicatorSyneron Medical, Ltd.2005456—
+7K051681Dermillume Red, Model HR1000Care Electronics, Inc.20053—
+7K041969Aurora DSSyneron Medical, Ltd.2004302—
+8K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC20260—
+8K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+8K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+8K262364Ellian Enigma RF DeviceEllian Corp20260—
+8K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+8K253504Volnewmer™Classys, Inc.20260—
+8K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+8K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+8K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+8K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+8K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+8K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+8K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical20260—
+8K253750BTL-785NEHBTL Industries, Inc.20260—
+8K252561BTL-754FFBTL Industries, Inc.20260—
+8K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+8K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+8K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+8K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+8K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+8K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+8K253331PressON Spinal Fixation SystemNexus Spine20250—
+8K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+8K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+8K252437JAZZ Spinal SystemImplanet20250—
+8K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+8K250065DENSITY; DENZA; DENSITY NoirJeisys Medical Incorporated20250—
+8K251632Optimas MAX SystemInMode, Ltd.20251—
+8K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation202521
+8K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+8K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+8K242464Stealth™ Spine Clamps; ModuLeX™ Shank MountsMedtronic Navigation, Inc.20251—
+8K251433Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo…Surgify Medical OY202513
+8K250224handLITE (TN19S)iSMART Developments, Ltd.20250—
+8K250189AdvaTxAdvalight Aps20250—
+8K250403Catamaran SI Joint Fusion SystemTenon Medical20251—