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
+8K153566Magma SystemFormatk Systems, Ltd.20162—
+8K152280BioPhotas Celluma3Biophotas, Inc.201649—
+8K152332Perfectio LED infrared deviceOmm Imports Inc Dba Zero Gravity201661—
+8K153341Relieva Scout Multi-Sinus Dilation SystemAcclarent, Inc.20160—
+8K143713Lustre PRO Light SystemAmbicare Health, Ltd.20162—
+8K152889Sonilase Blue, Sonilase Blue-Clean, Sonilase Blue-UV Clean PlusBiorenew Labs, LLC20153—
+8K152714Quanta ForteQuanta System Spa201513—
+8K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+8K152121NuVent EM Sinus Dilation SystemMedtronic Xomed, Inc.20150—
+8K152248CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.20150—
+8K143738DSS Sinusplasty Balloon CatheterIntuit Medical Products, LLC20150—
+8K143554Venus Legacy CXVenus Concept, Ltd.201517—
+8K143559XP1000 RFBTL Industries, Inc.20157—
+8K150282Shaser Skin Beauty Intense Pulsed Light System Family for AcneShaser, Inc.20150—
+8K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+8K150035V10 systemViora, Ltd.201531—
+8K143541Relieva SpinPlus Balloon Sinuplasty SystemAcclarent, Inc.20152—
+8K150098LightStim Professional 2-Panel LightLed Intellectual Properties, LLC201510—
+8K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+8K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+8K140471Pro X Otc 5La Lumiere, LLC2015107—
+8K142910Legacy BXVenus Concept USA, Inc.201411—
+8K141904Viora V-TouchViora, Ltd.20140—
+8K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S201461
+8K133546Starlite-OM, Light Effects, ThibiantPs Advanced Engineering20140—
+8K140629Venus Swan (MP)2Venus Concept, Ltd.20140—
+8K140255Stop U (Packed Black Usa); Stop U (Packed White Usa)Pollogen, Ltd.20147—
+8K133837Viora V-TotalViora, Ltd.201433—
+8K140160Relieva Scout Sinus Dilation SystemAcclarent, Inc.20140—
+8K131113Biophotas CellumaBiophotas, Inc.201455—
+8K131461Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC201481—
+8K131758Surgen UPollogen, Ltd.20135—
+8K133016Vent-OS Sinus Dilation SystemSinusys Corporation20130—
+8K130459Tria Fan SystemTria Beauty, Inc.20131—
+8K131362Inmode Wmbody DeviceInmode MD, Ltd.201317—
+8K131709Sinus Dilation System with Cannulated InstrumentArthrocare Corp.20130—
+8K132665Pelleve Glidesafe 10MM, 15MM & 20MM Handpiece, Pelleve S5 - IecEllman International, Inc.201317—
+8K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+8K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+8K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+8K122579VelashapeSyneron Medical, Ltd.20124—
+8K121174Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201220—
+8K110375Blueshine's Gold SeriesBlueshine Srl20124—
+8K113522Pathassist Light SeekerEntellus Medical, Inc.20122—
+8K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+8K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+8K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+8K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+8K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+8K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+8K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+8K101321Ematrix CO2Syneron Medical, Ltd.20102—
+8K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+8K101366I-Lipo, Models A00-1238 (230V), A00-1239 (120V)Chromogenex Technologies, Ltd.201016—
+8K100143Pilot Diode Laser, Model 002-00139CAO Group, Inc.201020—
+8K100558Quanta Diode Laser SystemQuanta System Spa201068—
+8K100230Smoothshapes System, 11318-120V, 11319-230VEleme Medical, Inc.201026—
+8K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+8K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+8K090094Zeltiq SystemZeltiq Aesthetics200932—
+8K083629SmoothshapesEleme Medical, Inc.200927—
+8K083682180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc.2009121—
+8K082938EzlaseBiolase Technology, Inc.200850—
+8K081570DPL Therapy SystemLed Technologies, LLC200811
+8K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+8K082445CURATIVE980 Diode LaserOroscience, Inc.20080—
+8K082197Rhytec, Inc., Portrait PSRRhytec Incorporated20083—
+8K081015Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc.200834—
+8K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+8K073322Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH200822—
+8K070690The Life VesselCottonwood Vessel Corporation20070—
+8K050796Aurora DS, DS ApplicatorSyneron Medical, Ltd.2005301—
+9K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+9K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—
+9K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+9K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+9K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+9K261582Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+9K261964Echolaser X4Elesta S.P.A20260—
+9K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+9K261473ChromixTermosalud S.L.20260—
+9K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+9K253656OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation SystemMedtronic Sofamor Danek USA, Inc.20260—
+9K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—
+9K261374LigaPASS™ SystemMedicrea International S.A.S20260—
+9K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+9K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+9K260688Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+9K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+9K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+9K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd.20261—
+9K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+9K253627Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo…Surgify Medical OY2026011
+9K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+9K260511Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+9K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+9K252989“POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories SetPoint Robotics MedTech, Inc.20260—
+9K243854Contour Light (CL-100)Contour Research, LLC20261—
+9K252755POINT Kinguide Agile Robotic Arm Surgical Stereotactic SystemPoint Robotics MedTech, Inc.20260—
+9K253054LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.20250—