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
- K153080RTVue XR OCT Avanti with AngioVue Software2Cleared 510(K)
- K150722EnFocus 2300, EnFocus 44002Cleared 510(K)
- K142953OCT-Camera2Cleared 510(K)
- K141638PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE2Cleared 510(K)
- K133758CENTERVUE MACULAR INTEGRITY ASSESSMENT2Cleared 510(K)
- K131939AMICO DH-W35 OPHTHALMOSCOPE SERIES2Cleared 510(K)
- K133892IVUE 5002Cleared 510(K)
- K123316HEINE OMEGA 5002Cleared 510(K)
- K121739IVUE WITH NORMATIVE DATABASE2Cleared 510(K)
- K120057ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS)2Cleared 510(K)
- K120238RTVUE XR OCT2Cleared 510(K)
- K111531RHA20202Cleared 510(K)
- K103266ISTAND2Cleared 510(K)
- K110205AAIO-7, AAIO WIRLESS2Cleared 510(K)
- K101505RTVUE MODEL RTVUE 1002Cleared 510(K)
- K100861R T VUE WITH SOFTWARE 5.0 MODEL: R I VUE 1002Cleared 510(K)
- K063378CIRRUS HD-OCT, MODEL 40002Cleared 510(K)
- K063343BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM2Cleared 510(K)
- K061674RTA 5 & RTA MODEL E RETINAL THICKNESS ANALYZER2Cleared 510(K)
- K060822VANTAGE INDIRECT OPHTHALMOSCOPE2Cleared 510(K)
- K051789VISANTE OCT2Cleared 510(K)
- K042885OCT-OPTHALMOSCOPE2Cleared 510(K)
- K042001PANORAMIC 200A2Cleared 510(K)
- K041290RTA MODEL D RETINAL THICKNESS ANALYZER2Cleared 510(K)
- K033123STRATUSOCT WITH RNFL & MACULA NORMATIVE DATABASE2Cleared 510(K)
- K031312RTA MODEL D RETINAL THICKNESS ANALYZER2Cleared 510(K)
- K030433STRATUSOCT WITH RNFL NORMATIVE DATABASE2Cleared 510(K)
- K003376WELCH ALLYN 11800 OPTHALMOSCOPE2Cleared 510(K)
- K994340CLINICAL SPECULAR MICROSCOPE, MODEL HAI CL-1000XYZ2Cleared 510(K)
- K992606CANON LASER BLOOD FLOWMETER (CLBF) MODEL 1002Cleared 510(K)
- K000731MODIFICATION TO RTA RETINAL THICKNESS ANALYZER2Cleared 510(K)
- K983999PANORAMIC200 OPTHALMOSCOPE2Cleared 510(K)
- K981640S2LO2Cleared 510(K)
- K971671HEIDELBERG RETINA ANGIOGRAPH FA/ICGA (HRA/C)2Cleared 510(K)
- K951728SCHEPENS-YOSHIDA VIDEO BINOCULAR INDIRECT OPHTHALMSCOPE2Cleared 510(K)
- K964137RTA RETINAL THICKNESS ANALYZER2Cleared 510(K)
- K961171HUMPHREY OCT SCANNER2Cleared 510(K)
- K951132ANGIOSCAN (AS STAND ALONE INSTRUMENT)2Cleared 510(K)
- K951210WELCH ALLYN VIDEO OPHTHALMOSCOPE2Cleared 510(K)
- K951338INDIRECT OPHTHALMOSCOPE VIDEO SYSTEM IO0 A TV2Cleared 510(K)
- K950461WELCH ALLYN OPHTHALMOSCOPE2Cleared 510(K)
- K944261RETINA ANGIOGRAPH2Cleared 510(K)
- K943956RETINA TOMOGRAPH AND FLOWMETER2Cleared 510(K)
- K943955RETINA FLOWMETER2Cleared 510(K)
- K942713NEITZ HALOGEN BINOCULAR INDIRECT OPHTHALMOSCOPE IO-H2Cleared 510(K)
- K942711NEITZ HALOGEN OPHTHALMOSCOPE BXA-1232Cleared 510(K)
- K942712NEITZ HALOGEN BINOCULAR INDIRECT OPHTHALMOSCOPE IO-A2Cleared 510(K)
- K942714NEITZ HALOGEN OPHTHALMOSCOPE BXA-RP2Cleared 510(K)
- K942715NEITZ HALOGEN OPHTHALMOSCOPE BXA-RC2Cleared 510(K)
- K942720NEITZ HALOGEN OPHTHALMOSCOPE BXA-122Cleared 510(K)
- K942104KEELER VANTAGE INDIRECT OPHTHALMOSCOPE2Cleared 510(K)
- K941705NERVE FIBER ANALYZER2Cleared 510(K)
- K935988R&D BATTERIES # 5615, 5234, 50972Cleared 510(K)
- K930023MODEL #12000 BINOCULAR INDERECT OPHTHALMOSCOPE2Cleared 510(K)
- K923742TOPOGRAPHIC SCANNING SYSTEM TOPSS2Cleared 510(K)
- K921163REGALTECH MAXISCOPE2Cleared 510(K)
- K914484LITESPOT(TM) LASER INDIRECT OPHTHALMOSCOPE2Cleared 510(K)
- K912581ZEISS CONFOCAL LASER SCANNING OPHTHALMOSCOPE(CLSO)2Cleared 510(K)
- K912397PROFESSIONAL INDIRECT OPHTHALMOSCOPE2Cleared 510(K)
- K913118GLAUCOMA-SCOPE2Cleared 510(K)
- K912891HEIDELBERG RETINA TOMOGRAPH2Cleared 510(K)
- K900111KEELER KONAN SPECULAR MICROSCOPE SP33002Cleared 510(K)
- K895010MENTOR SPECTACLE BINOCULAR INDIRECT OPHTHALMOSCOPE2Cleared 510(K)
- K893172VISTA OPHTHALMOSCOPE (BATTERY AND AC-POWERED)2Cleared 510(K)
- K893173VISTA SPECIALIST OPHTHALMOSCOPE (BATTERY & AC)2Cleared 510(K)
- K882517RODENSTOCK SCANNING LASER OPHTHALMOSCOPE2Cleared 510(K)
- K881984EOL, MODEL LIO2Cleared 510(K)
- K871268RODENSTOCK SCANNING LASER OPHTHALMOSCOPE2Cleared 510(K)
- K854244THE KEELER ALL PUPIL INDIRECT OPHTHALMOSCOPE2Cleared 510(K)
- K851264AMER. MEDICAL OPTICS MONOCULAR INDIRECT OPHTHALMAS2Cleared 510(K)
- K851263AMER. MEDICAL OPTIC MONOCULAR DIRECT OPHTHALMASCOP2Cleared 510(K)
- K851262AMER. MEDICAL OPTICAL BINOCULAR INDIRECT OPHTHALMA2Cleared 510(K)
- K844971MONOCULAR DIRECT OPHTHALMOSCOPE2Cleared 510(K)
- K843596NIDEK-BINOCULAR INDIRECT OPHTHALMOSCOPE2Cleared 510(K)
- K843597NIDEK MONOCULAR INDIRECT OPHTHALMOSCOPE2Cleared 510(K)
- K844054CANON AUTO KERATOMETER K-12Cleared 510(K)
- K843812WOODLYN CLASSIC CATARACT ACUITY TEST2Cleared 510(K)
- K843304BINOCULAR INDIRECT OPHTHALMOSCOPE2Cleared 510(K)
- K843099MAMIYA SLIT LAMP P-12Cleared 510(K)
- K841761WOODLYN CLASSIC SLIT LAMP HSSL-CL2Cleared 510(K)
- K841767WOODLYN CLASSIC KERATOMETER2Cleared 510(K)
- K841764WOODLYN CLASSIC JAVAL OPHTHALMOMETER2Cleared 510(K)
- K841763WOODLYN SLIT LAMP HSSL-EC2Cleared 510(K)
- K822104ALCON INDIRECT OPHTHALMOSCOPE2Cleared 510(K)
- K791510BLUE FIELD ENTOPTOSCOPE BFE1002Cleared 510(K)
- K772214OPHTHALMOSCOPE, BINOCULAR, INDIRECT2Cleared 510(K)
- K770768OPHTHALMOSCOPE, MODEL #111002Cleared 510(K)
- 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
- 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
ISTAND
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K103266
- 510(k) Type
- Traditional
- Applicant
- Optovue, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/3/2011
- Days to Decision
- 211 days
- Submission Type
- Summary