Anesthesiology
Review Panel
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- 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
- K242184Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256);2Cleared 510(K)
- K233653Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00)2Cleared 510(K)
- K221872ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System2Cleared 510(K)
- K202670Nam illumination probe with chopper2Cleared 510(K)
- K15160423ga Chandelier Illuminator, 25ga Chandelier Illuminator2Cleared 510(K)
- K143123Synergetics PHOTON EX2Cleared 510(K)
- K080067ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETER2Cleared 510(K)
- K062895XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII2Cleared 510(K)
- K062259ISCIENCE SURGICAL FIBEROPTIC ILLUMINATOR, MODEL FI - 1002Cleared 510(K)
- K041108ISCIENCE SURGICAL OPHTHALMIC MICROCANNULA2Cleared 510(K)
- K032598SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE2Cleared 510(K)
- K000252INSIGHT 4000 ENDOSCOPE2Cleared 510(K)
- K000416TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 900012Cleared 510(K)
- K980797PEREGRINE FIBER OPTIC MULTI-FUNCTION MANIPULATOR2Cleared 510(K)
- K980530PEREGRINE FIBER OPTIC BIPOLAR STRAIGHT PICK AND ANGLED PICK, MODELS PD100.12 AND PD100.132Cleared 510(K)
- K980027PEREGRINE SHIELDED DIFFUSION PROBE2Cleared 510(K)
- K980025PEREGRINE TAPERED DIFFUSION PROBE2Cleared 510(K)
- K973229D.O.R.C. HEXON ILLUMINATION SYSTEM2Cleared 510(K)
- K973293SYNTEC TRUE LIGHT END IRRIGATING ENDOILLUMINATOR2Cleared 510(K)
- K973290SYNTEC TRUE LIGHT ENDOILLUMIINATOR WITH PICK2Cleared 510(K)
- K973757D.O.R.C. SOLUX LIGHT SOURCE2Cleared 510(K)
- K971679I-SCOPE OPHTHALMIC ENDOSCOPE2Cleared 510(K)
- K970882ENDOLIGHT END IRRIGATING ENDO-ILLUMINATOR (20 GA. AND 19 GA.)2Cleared 510(K)
- K964005SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE2Cleared 510(K)
- K970875ENDOLIGHT FIBEROPTIC ENDO-ILLUMINATOR (20 GA. & 19 GA.)2Cleared 510(K)
- K964553MBI CO-AXIAL ILLUMINATED RETINAL PICK2Cleared 510(K)
- K964405MBI ILLUMINATED RETINAL PICK2Cleared 510(K)
- K971338SYNTEC, INC. DISPOSABLE BARE END FIBER2Cleared 510(K)
- K970878ENDOLIGHT FIBEROPTIC REGULAR MONOFILAMENT AND FINE MONOFILAMENT2Cleared 510(K)
- K964555VITROTEC TRUE LIGHT ENDOILLUMINATOR (100-S)2Cleared 510(K)
- K963417VITLITE (TR7700)2Cleared 510(K)
- K961036MBI FIBEROPTIC ENDO-ILLUMINATOR2Cleared 510(K)
- K960007STORZ MVS 1011A DISPOSABLE FIBEROPTIC ENDOILLUMINATOR2Cleared 510(K)
- K952585GAMP & ASSOCIATES DISPOSABLE END IRRIGATING ENDOILLUMINATOR2Cleared 510(K)
- K952581GAMP & ASSOCIATES DISPOSABLE FIBEROPTIC VISCOINJECTOR2Cleared 510(K)
- K951627INFINITECH HIGH INTENSITY XENON LIGHT SOURCE SYSTEM2Cleared 510(K)
- K946136INFINITECH LIGHTED INFUSION CANNULA2Cleared 510(K)
- K952580GAMP & ASSOCIATES DISPOSABLE BARE END FIBER2Cleared 510(K)
- K952586GAMP & ASSOCIATES DISPOSABLE FIBEROPTIC ENDOILLUMINATOR2Cleared 510(K)
- K952584GAMP & ASSOCIATES DISPOSABLE ENDOILLUMINATOR W/PICK2Cleared 510(K)
- 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
I-SCOPE OPHTHALMIC ENDOSCOPE
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K971679
- 510(k) Type
- Traditional
- Applicant
- OPHTHALMIC TECHNOLOGIES, INC.
- Country
- Canada
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/25/1997
- Days to Decision
- 49 days
- Submission Type
- Summary