Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- HKXTonometer, Ac-Powered2Product Code
- HKYTonometer, Manual2Product Code
- HKZSterilizer, Tonometer1Product Code
- HLACalibrator, Tonometer2Product Code
- HLCInstrument, Measuring, Stereopsis1Product Code
- HLERuler, Nearpoint (Punctometer)1Product Code
- HLFDevice, Measuring, Lens Radius, Ophthalmic1Product Code
- HLGPupillometer, Ac-Powered1Product Code
- HLHPupillometer, Manual1Product Code
- HLIOphthalmoscope, Ac-Powered2Product Code
- HKMRetinoscope, Battery-Powered1Product Code
- HKNRefractor, Manual, Non-Powered, Including Phoropter1Product Code
- HKORefractometer, Ophthalmic1Product Code
- HKQPrism, Rotary, Ophthalmic1Product Code
- HKRLens, Maddox1Product Code
- HKSPrism, Gonioscopic1Product Code
- HKTPrism, Fresnel, Ophthalmic1Product Code
- HKWPrism, Bar, Ophthalmic1Product Code
- KYHEndoscope, Ophthalmic2Product Code
- MPAEndoilluminator2Product Code
- NKZEndoilluminator, Reprocessed2Product Code
- HITTester, Color Vision1Product Code
- HIWAnomaloscope1Product Code
- HIXMaxwell Spot, Ac-Powered1Product Code
- HIYBrush, Haidinger, (Including Macular Integrity)1Product Code
- HJAPhotokeratoscope1Product Code
- HJBInstrument, Measuring, Corneal Radius1Product Code
- HJCEsthesiometer, Ocular1Product Code
- HJDIlluminator, Color Vision Plate1Product Code
- HJILens, Fundus, Hruby, Diagnostic1Product Code
- HJJLens, Fresnel, Flexible, Diagnostic1Product Code
- HJKLens, Contact, Polymethylmethacrylate, Diagnostic2Product Code
- HJLLens, Condensing, Diagnostic1Product Code
- HJMTransilluminator, Ac-Powered2Product Code
- HJNTransilluminator, Battery-Powered1Product Code
- HJOBiomicroscope, Slit-Lamp, Ac-Powered2Product Code
- K231760HP-OCT (HP-OCT)2Cleared 510(K)
- K222372Kowa SL-192Cleared 510(K)
- K193188MiiS Horus Eye Anterior Camera2Cleared 510(K)
- K182306Sunkingdom Slit Lamp2Cleared 510(K)
- K173771IOLMaster 7002Cleared 510(K)
- K171877SLM-1ER, SLM-2ER, SLM-3ER2Cleared 510(K)
- K170470Digital Eye Anterior Camera2Cleared 510(K)
- K162778Portable Slit Lamp Microscope2Cleared 510(K)
- K162684SL 2202Cleared 510(K)
- K163564SLIT LAMP SL-20002Cleared 510(K)
- K162636Marco Ultra M3, Marco Ultra M42Cleared 510(K)
- K170171IOLMaster 7002Cleared 510(K)
- K161607VISULUX2Cleared 510(K)
- K161764SLIT LAMP, Model: YF-1002Cleared 510(K)
- K161972Slit Lamp SL-D3012Cleared 510(K)
- K160327ALADDIN HW3.02Cleared 510(K)
- K153545Portable Slit Lamp2Cleared 510(K)
- K152535Z5 Slit lamp microscope, Z2 Slit lamp microscope2Cleared 510(K)
- K152429Slit Lamp Microscope2Cleared 510(K)
- K151394Keeler Slit Lamp2Cleared 510(K)
- K143275IOLMaster7002Cleared 510(K)
- K141954XCEL 455 SLIT LAMP2Cleared 510(K)
- K141068ZEISS CATARACT SUITE MARKERLESS2Cleared 510(K)
- K133667SLIT LAMP SL-D7012Cleared 510(K)
- K140451KEELER SLIT LAMP H-SERIES DIGITAL (HALOGEN BULB OPTION), KEELER SLIT LAMP H-SERIES DIGITAL (LED OPTION)2Cleared 510(K)
- K133062DISCOVERY SYSTEM2Cleared 510(K)
- K133132OPTICAL BIOMETER AL-SCAN2Cleared 510(K)
- K131567ALADDIN2Cleared 510(K)
- K131711YZ3 PORTABLE SLIT LAMP2Cleared 510(K)
- K133755KOWA SL-172Cleared 510(K)
- K133476SLIT LAMPS WITH SL CAM 5.0 DIGITAL IMAGING SOLUTION2Cleared 510(K)
- K131589KEELER SLIT LAMP H-SERIES2Cleared 510(K)
- K122418IOLMASTER 5002Cleared 510(K)
- K110129RIGHTON ZOOM SLIT LAMP MICROSCOPE WITH PHOTO OPTION2Cleared 510(K)
- K110489SLIT LAMP SL-2G2Cleared 510(K)
- K101182IOLMASTER 5002Cleared 510(K)
- K100439MEDIWORKS SLIT LAMP2Cleared 510(K)
- K100202SLIT LAMP BO 900, BQ 900, BP9002Cleared 510(K)
- K100500PSL CLASSIC SLIT LAMP2Cleared 510(K)
- K093021ATLANTIS SLIT LAMP2Cleared 510(K)
- K092883LED LAMP OR OTHER2Cleared 510(K)
- K093639SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-75002Cleared 510(K)
- K082891LENSTAR, MODEL LS9002Cleared 510(K)
- K080776GILRAS SLIT LAMP, MODELS GR-SL7, GR-SL36, GR-SL54 AND GR-SL722Cleared 510(K)
- K082031APPASAMY SLIT LAMP, A1A-11 AND A1A-12 SERIES2Cleared 510(K)
- K072861CEEMAX SLIT LAMP (HALOGEN LAMP SERIES/SOLID STATE ILLUMINATION SERIES)2Cleared 510(K)
- K073190SLIT LAMP2Cleared 510(K)
- K063352ELLEX SLIT LAMP, MODEL 30XL2Cleared 510(K)
- K063750XCEL 255 SLIT LAMP2Cleared 510(K)
- K063640KOWA SL-152Cleared 510(K)
- K063416LUXVISION SLIT LAMP2Cleared 510(K)
- K061330PSL PORTABLE SLIT LAMP2Cleared 510(K)
- K060869RS-1000 ZOOM SLITLAMP WITH OPTION2Cleared 510(K)
- K043503VISX CUSTOMVUE SLIT ILLUMINATOR WITH DESKTOP CHARGER, MODEL CV SI-12Cleared 510(K)
- K033190VISION-TECH YZ SLIT LAMP, MODEL 662Cleared 510(K)
- K012873DOCUMENTING LASER SLIT LAMP, DP 20102Cleared 510(K)
- K012416CONFOSCAN 2 CONFOCAL MICROSCOPE2Cleared 510(K)
- K993357IOLMASTER2Cleared 510(K)
- K992836SL990, SL980, SL9502Cleared 510(K)
- K982057BC 900 SLIT LAMP2Cleared 510(K)
- K973064KEELER TEARSCOPE-PLUS2Cleared 510(K)
- K974467AESCULAP-MEDITEC SLIT LAMPS SL07 AND SL082Cleared 510(K)
- K971953CONFOSCAN2Cleared 510(K)
- K970414CONFOCAL MICROSCOPE2Cleared 510(K)
- K962532RODENSTOCK SLITLAMP (MODEL 5000 & 4000)2Cleared 510(K)
- K962522MODEL SL-YZ5E2Cleared 510(K)
- K954782KOWA PORTABLE SLIT LAMP SL-14 & SL-14B2Cleared 510(K)
- K945445BOBES SLIT LAMP2Cleared 510(K)
- K953965904 SLIT LAMP2Cleared 510(K)
- K953030SLIT LAMP AIA 112Cleared 510(K)
- K951341NEITZ SLIT LAMP SL-H22Cleared 510(K)
- K951184OTI MODEL 78-602Cleared 510(K)
- K951340NEITZ SLIT LAMP SL-H12Cleared 510(K)
- K951054XCEL SLIT LAMP2Cleared 510(K)
- K944910TOMEY EM-1000 SPECULAR MICROSCOPE2Cleared 510(K)
- K936209SLIT LAMP, H-2012Cleared 510(K)
- K930518TALIA LASER SLIT2Cleared 510(K)
- K925641ZEISS 20 SL SLIT-LAMP & MECHANICAL MICROMANIPULATR2Cleared 510(K)
- K930438MARCO MODELS G,H AND PRIMARY CARE SLIT LAMPS2Cleared 510(K)
- K924783BURTON SLIT LAMP - MODEL 8502Cleared 510(K)
- K924770BURTON HAND HELD SLIT LAMP - MODEL SL7502Cleared 510(K)
- K924787BURTON SLIT LAMP2Cleared 510(K)
- K924782BURTON SLIT LAMP - MODEL 20002Cleared 510(K)
- K915356OPACITRAC2Cleared 510(K)
- K913852LASER FLARE METER2Cleared 510(K)
- K912514TANDEM SCANNING MICROSCOPE2Cleared 510(K)
- K910980SITE 20 GAUGE REUSABLE FIBER OPTIC CABLE2Cleared 510(K)
- K900477WOODLYN CLASSIC SLIT LAMP MODEL SMM2Cleared 510(K)
- K900476WOODLYN SLIT LAMP MODEL HR-12Cleared 510(K)
- K880920LASER FLARE CELL METER FC-10002Cleared 510(K)
- K874160ZEISS 40 SL/P PHOTO SLIT LAMP2Cleared 510(K)
- K874220OCS 100 (OCULAR COMPARATOR SYSTEM)2Cleared 510(K)
- K863970MLC ENDOTHELIAL CELL COUNTER2Cleared 510(K)
- K863048OPM SLIT LAMP MODEL P-1 & MODEL P-32Cleared 510(K)
- K862379CORNEAL MODELING SYSTEM2Cleared 510(K)
- K862516BAUSCH & LOMB OSL-2000 SLIT LAMP2Cleared 510(K)
- K862515BAUSCH & LOMB CSL-1000 SLIT LAMP2Cleared 510(K)
- K862520BAUSCH & LOMB PSL-3000 SLIT LAMP2Cleared 510(K)
- K861854OPM SLIT LAMP MODEL P-12Cleared 510(K)
- K862004ZEISS 30 SL-L2Cleared 510(K)
- K842859MICROSCOPE MITTS SUPPORT TRAY COVER2Cleared 510(K)
- K832911ABBOTT GLOBE HOLDER2Cleared 510(K)
- K813313BIOMICROSCOPY CONTACT LENS2Cleared 510(K)
- K811153COHERENT FLOUROTRON MASTER2Cleared 510(K)
- K810403KEELER/KONAN SPECULAR MICROSCOPE2Cleared 510(K)
- K802355METRICON #120 FLUOROPHOTOMETER2Cleared 510(K)
- K801659BIOPHTAL CLINICAL ENDOTHELIAL MICROSCOPE2Cleared 510(K)
- HJQStereoscope, Ac-Powered1Product Code
- HJRStereoscope, Battery-Powered1Product Code
- HJSTest, Spectacle Dissociation, Ac-Powered (Lancaster)1Product Code
- HJTHaploscope1Product Code
- HJWAdaptometer (Biophotometer)1Product Code
- HKDTape, Nystagmus1Product Code
- HKFMirror, Headband, Ophthalmic1Product Code
- HKGFornixscope1Product Code
- HKICamera, Ophthalmic, Ac-Powered2Product Code
- HKLRetinoscope, Ac-Powered2Product Code
- HLJOphthalmoscope, Battery-Powered2Product Code
- HLKScreen, Tangent, Target, Battery-Powered1Product Code
- HLLMonitor, Eye Movement2Product Code
- HLMInstrument, Measuring, Lens, Ac-Powered1Product Code
- HLNGauge, Lens, Ophthalmic1Product Code
- HLOTest, Spectacle Dissociation, Battery-Powered (Lancaster)1Product Code
- HLPTarget, Fusion And Stereoscopic1Product Code
- HLQKeratoscope, Ac-Powered1Product Code
- HLRKeratoscope, Battery-Powered1Product Code
- HLSExophthalmometer1Product Code
- HLTPreamplifier, Ac-Powered, Ophthalmic2Product Code
- HLWPreamplifier, Battery-Powered, Ophthalmic2Product Code
- HLXPhotostimulator, Ac-Powered2Product Code
- HLZElectrode, Corneal2Product Code
- HMCMonitor, Eye Movement, Diagnostic2Product Code
- HMDChair, Ophthalmic, Manual1Product Code
- HMEChair, Ophthalmic, Ac-Powered1Product Code
- HMFStand, Instrument, Ac-Powered, Ophthalmic1Product Code
- HMGStand, Instrument, Ophthalmic, Non-Powered1Product Code
- HMHRack, Skiascopic1Product Code
- HMJScreen, Tangent, Projection, Battery-Powered1Product Code
- HMKEuthyscope, Ac-Powered2Product Code
- HMLEuthyscope, Battery-Powered1Product Code
- HMMDistometer1Product Code
- HOJScreen, Tangent, Target1Product Code
- HOKScreen, Tangent, Projection, Ac-Powered1Product Code
- HOLScreen, Tangent, Felt (Campimeter)1Product Code
- HOMScreen, Tangent, Ac-Powered (Campimeter)1Product Code
- HONPerimeter, Manual1Product Code
- HOOPerimeter, Ac-Powered1Product Code
- HOPCampimeter, Stereo, Battery-Powered1Product Code
- HOQGrid, Amsler1Product Code
- HORSimulatan (Including Crossed Cylinder)1Product Code
- HOSProjector, Ophthalmic1Product Code
- HOWDrum, Opticokinetic1Product Code
- HOXChart, Visual Acuity1Product Code
- HPAFrame, Trial, Ophthalmic1Product Code
- HPBClip, Lens, Trial, Ophthalmic1Product Code
- HPCSet, Lens, Trial, Ophthalmic1Product Code
- HPDLens, Bagolini1Product Code
- HPJInstrument, Visual Field, Laser2Product Code
- HPKTonograph2Product Code
- HPLDevice, Fixation, Ac-Powered, Ophthalmic1Product Code
- HPTPerimeter, Automatic, Ac-Powered1Product Code
- HPWProbe And Counter, Isotope, For Phosphorus 322Product Code
- HRECabinet, Instrument, Ac-Powered, Ophthalmic1Product Code
- HRIPupillograph1Product Code
- KYDStrip, Schirmer1Product Code
- MMFPhotorefractor2Product Code
- MMQTopographer, Corneal, Ac-Powered1Product Code
- MSGOphthalmoscopes, Replacement Batteries, Hand-Held2Product Code
- MXKDevice, Analysis, Anterior Segment2Product Code
- MYCOphthalmoscope, Laser, Scanning2Product Code
- NCFAberrometer, Ophthalmic1Product Code
- NFDSelector, Color, Spectacle, Lens, Tint1Product Code
- NJGFlasher, Afterimage, Ophthalmic2Product Code
- NJJTonometer, Analyzer, Ocular Blood Flow2Product Code
- NOGTopographer, Corneal, Battery Powered1Product Code
- NOHPhotokeratoscope, Battery Powered1Product Code
- NOIStand, Instrument, Ophthalmic, Battery Powered1Product Code
- NQEMicroscope, Specular2Product Code
- NXRFixation, Vision Training, Binocular1Product Code
- NYKOphthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (Pmma)2Product Code
- OBOTomography, Optical Coherence2Product Code
- OUMAdaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus Generation1Product Code
- PIBDiabetic Retinopathy Detection Device2Product Code
- PJZCamera, Ophthalmic, General-Use2Product Code
- PLZOcular Pattern Recorder2Product Code
- PMWStrabismus Detection Device2Product Code
- PUEBiomicroscope, Slit-Lamp, Ac-Powered, Exempt2Product Code
- QERCamera, Ophthalmic, Slit-Scanning2Product Code
- NFFDevice, Storage, Images, Ophthalmic1Product Code
- NFGDevice, Communications, Images, Ophthalmic1Product Code
- NFHDigitizer, Images, Ophthalmic2Product Code
- NFIDevice, Hardcopy, Images, Ophthalmic2Product Code
- NFJSystem, Image Management, Ophthalmic2Product Code
- QTODigital Visual Acuity Test1Product Code
- QTWDigital Amsler Grid1Product Code
- QZPCamera, Ophthalmic, Non-Prescription2Product Code
- SBIManual Refractor, 3d Display1Product Code
- SBNDigital Therapy Device For Convergence Insufficiency1Product Code
- SCWDigital Prismatic Correction1Product Code
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
Marco Ultra M3, Marco Ultra M4
- Page Type
- Cleared 510(K)
- 510(k) Number
- K162636
- 510(k) Type
- Traditional
- Applicant
- TAKAGI SEIKO CO.LTD.
- Country
- Japan
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/14/2017
- Days to Decision
- 205 days
- Submission Type
- Summary