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
- 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
- K250770Optina-4C (MHRC-C1N)2Cleared 510(K)
- K2436003nethra neo HD FA; 3nethra neo HD2Cleared 510(K)
- K250683Resolve Fundus Camera2Cleared 510(K)
- K243664Sentinel Camera2Cleared 510(K)
- K242508Verily Numetric Retinal Camera2Cleared 510(K)
- K241049CANON Fundus Camera CR-10 (CR-10)2Cleared 510(K)
- K231230Optina-4C (MHRC-C1N)2Cleared 510(K)
- K230627Zilia Ocular FC (ZIL-10002)2Cleared 510(K)
- K223575Phoenix ICON, Phoenix ICON GO2Cleared 510(K)
- K223381iExaminer System with Panoptic Plus2Cleared 510(K)
- K221329Eyer Retinal Camera NM-STD2Cleared 510(K)
- K221111Non-Mydriatic Retinal Camera NW5002Cleared 510(K)
- K210197NFC-600 Automated Portable Retinal Camera2Cleared 510(K)
- K203500RetCam Envision2Cleared 510(K)
- K202097Fundus Camera2Cleared 510(K)
- K202221VX6502Cleared 510(K)
- K201325Optomed Smartscope M5 with Optomed Smartscope FA2Cleared 510(K)
- K201122Canon non-mydriatic retinal camera CR series2Cleared 510(K)
- K193319XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System2Cleared 510(K)
- K200254Mydriatic Hyperspectral Retinal Camera (MHRC-C1)2Cleared 510(K)
- K190954Fundus Camera2Cleared 510(K)
- K191945KOWA nonmyd 82Cleared 510(K)
- K190573KOWA DR-1a2Cleared 510(K)
- K190198Microperimeter MP-3, Microperimeter MP-3 Type S2Cleared 510(K)
- K182199NFC-700 non-mydriatic auto fundus camera2Cleared 510(K)
- K1830593nethra neo2Cleared 510(K)
- K182506LipiScan Dynamic Meibomian Imager2Cleared 510(K)
- K182263RetCam 3 ; RetCam Shuttle ; RetCam Portable2Cleared 510(K)
- K173474RetiCapture2Cleared 510(K)
- K180306Nexy2Cleared 510(K)
- K180378Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module2Cleared 510(K)
- K170527Phoenix Clinical ICON2Cleared 510(K)
- K163021HAAG-STREIT FUNDUS MODULE 3002Cleared 510(K)
- K161727Eyenez Ophthalmic Camera2Cleared 510(K)
- K152729MICROPERIMETER MP-32Cleared 510(K)
- K153239LSFG-NAVI2Cleared 510(K)
- K152869LipiView II Ocular Surface Interferometer2Cleared 510(K)
- K141325TRC-NW8F PLUS NON-MYDRIATIC RETINAL CAMERA2Cleared 510(K)
- K141481TRC-NW400 NON-MYDRIATIC RETINAL CAMERA2Cleared 510(K)
- K132987COBRA FUNDUS CAMERA2Cleared 510(K)
- K140450KEELER KAPTURE SOFTWARE2Cleared 510(K)
- K132186OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES22Cleared 510(K)
- K130656IFUSION2Cleared 510(K)
- K123101TRC-50DX RETINAL CAMERA2Cleared 510(K)
- K130289TRC-NW8 NON-MYDRIATIC RETINAL CAMERA2Cleared 510(K)
- K123208DIGITAL RETINAL CAMERA2Cleared 510(K)
- K123460TRC-NW300 NON-MYDRIATIC RETINAL CAMERA2Cleared 510(K)
- K122572ICAM FUNDUS CAMERA2Cleared 510(K)
- K122481LIPIVIEW OCULAR SURFACE INTERFEROMETER2Cleared 510(K)
- K121405PANOPTIC2Cleared 510(K)
- K120982DIGITAL EYE-FUNDUS CAMERA2Cleared 510(K)
- K113451NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EX2Cleared 510(K)
- K112330KOWA VX-202Cleared 510(K)
- K111771NON-CONTACT TEAR FILM THERMOGRAGH2Cleared 510(K)
- K111612DIGITAL RETINAL CAMERA2Cleared 510(K)
- K102412VISTA DIGITAL OPTHALMOSCOPE2Cleared 510(K)
- K110986OPTOMED SMARTSCOPE M5 EY3 AND M5 ES12Cleared 510(K)
- K102859RETCAM 3 OPTHALMIC IMAGING SYSTEM2Cleared 510(K)
- K101628KOWA NONMYD WX2Cleared 510(K)
- K102651ISCREEN VISION SCREENER2Cleared 510(K)
- K101861TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM2Cleared 510(K)
- K093071FUNDUS PHOTO OPHTHALMIC DIGITAL IMAGING SYSTEM, MODEL CFD-4402Cleared 510(K)
- K102013DIGITAL RETINAL CAMERA2Cleared 510(K)
- K101935CENTERVUE DIGITAL RETINOGRAPHY SYSTEM2Cleared 510(K)
- K092565DIGITAL RETINAL CAMERA CX-12Cleared 510(K)
- K100207NON-MYDRIATIC RETINAL CAMERA, MODEL TRC-NW8F2Cleared 510(K)
- K090326RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMS2Cleared 510(K)
- K092374OIS EYESCAN PORTABLE MODULAR IMAGING SYSTEM, MODEL OIS EYESCAN2Cleared 510(K)
- K091935LIPIVIEW OCULAR SURFACE INTERFEROMETER2Cleared 510(K)
- K092056OPTOMED SMARTSCOPE, MODEL M3-1 EY12Cleared 510(K)
- K091098KOWAGENESIS-DF2Cleared 510(K)
- K091683KOWA VX-10 A2Cleared 510(K)
- K090115RETINA CAMERA TRC-NW7SF MARK II2Cleared 510(K)
- K082196STATIC VESSEL ANALYZER2Cleared 510(K)
- K090466DIGITAL RETINAL CAMERA, CR-1 MARK II2Cleared 510(K)
- K083771RETCAM PORTABLE OPHTHALMIC IMAGING SYSTEM, MODEL RCP2Cleared 510(K)
- K083387MODIFICATION TO KOWA NONMYD ALPHA-DIII2Cleared 510(K)
- K081858RETCAM 3 OPHTHALMIC IMAGING SYSTEM2Cleared 510(K)
- K082767KOWA NONMYD ALPHA-DIII2Cleared 510(K)
- K080180MODIFICATION TO RETINAL FUNCTION IMAGER (RFI)2Cleared 510(K)
- K080883CR-12Cleared 510(K)
- K080681KOWA GENESIS-D2Cleared 510(K)
- K070231ORION2Cleared 510(K)
- K063717CF-12Cleared 510(K)
- K062416RETINAL FUNCTIONAL IMAGER (RFI)2Cleared 510(K)
- K062021KOWA VX-10I2Cleared 510(K)
- K062295IRI INTEGRATED RETINAL IMAGER2Cleared 510(K)
- K061768MP-1 MICROPERIMETER2Cleared 510(K)
- K062356KOWA NONMYD ALPHA-D2Cleared 510(K)
- K053044OPTO GLOBAL DIGITAL FUNDUS CAMERA SYSTEM MODEL ADS 1.52Cleared 510(K)
- K053026KOWA NONMYD 7, KOWA NONMYD A-D2Cleared 510(K)
- K050271KOWA GENESIS-D HAND-HELD RETINAL CAMERA2Cleared 510(K)
- K052268VISUCAM PRO NM2Cleared 510(K)
- K043213KOWA VX-102Cleared 510(K)
- K043222VISCUCAM C DIGITAL CAMERA2Cleared 510(K)
- K041367TOPCON MODEL TRC-NW200 NON-MYDRIATIC RETINAL CAMERA2Cleared 510(K)
- K041546DIGITAL FUNDUS CAMERA, MODEL CF-60DSI2Cleared 510(K)
- K040325PANORET, MODEL PNM 602Cleared 510(K)
- K031629CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI2Cleared 510(K)
- K023719MP-1 MICRO PERIMETER2Cleared 510(K)
- K020888FUNDUS AUTOIMAGER2Cleared 510(K)
- K022164ZETA DIAGNOSTIC RETINAL IMAGING SYSTEM2Cleared 510(K)
- K014274NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-10002Cleared 510(K)
- K011877FF450 PLUS FUNDUS CAMERA AND VISUPAC DIGITAL IMAGE ARCHIVING SYSTEM, OR FF450 PLUS VISUPAC SYSTEM2Cleared 510(K)
- K010315ISCREEN VISION SCREENER2Cleared 510(K)
- K002920MEGAVISION CPX, MEGAVISION FA, MODEL I AND II2Cleared 510(K)
- K003236RETINADX2Cleared 510(K)
- K001275RETCAM II2Cleared 510(K)
- K000368EYECAP IMAGING SYSTEM2Cleared 510(K)
- K990205DIGISCOPE OPHTHALMIC CAMERA2Cleared 510(K)
- K982689WINSTATION RETINAL IMAGER2Cleared 510(K)
- K974535DISCAM DIGITAL IMAGING SYSTEM2Cleared 510(K)
- K980295OPHTHAVISION IMAGING SYSTEM2Cleared 510(K)
- K980246NON-MYDRIATIC RETINAL CAMERA, MODEL CR6-45NM2Cleared 510(K)
- K980357KONAN NONCON ROBO PACHY SPECULAR MICROSCOPE AND OPTICL PACHYMETER2Cleared 510(K)
- K973950RETINAL CUBE2Cleared 510(K)
- K973533NIDEK STEREO DISC CAMERA(3-DX)/NIDEK STEREO FUNDUS CAMERA(3-DXF)2Cleared 510(K)
- K973218NIDEK HANDY2Cleared 510(K)
- K972440CATARACTSCREENER CT - S2Cleared 510(K)
- K971685IMAGESCAPE DIGITAL RETINAL IMAGE SYSTEM2Cleared 510(K)
- K963333OPTRONICS EPIC COLOR TELEVISION CAMERA SYSTEM (S97340)2Cleared 510(K)
- K955442KOWA SC-1200 PHOTO SLIT LAMP SYSTEM2Cleared 510(K)
- K954781KOWA GENESIS HAND-HELD FUNDUS CAMERA2Cleared 510(K)
- K954780KOWA PROFESSIONAL FUNDUS CAMERA MODELS FX-500, FX-500S, FX-500C2Cleared 510(K)
- K953972ANGIOVISION VIEWING STATION2Cleared 510(K)
- K953973ANGIOVISION 10002Cleared 510(K)
- K952480ORIMS DIGITAL ANGIOGRAPHY SYSTEM2Cleared 510(K)
- K941234NON-MYDRIATIC RETINAL CAMERA2Cleared 510(K)
- K950091KONAN NONCON ROBO SPECULAR MICROSCOPE, MODELS SP 6000 AND SP 80002Cleared 510(K)
- K94605860 FUNDUS CAMERA CF-60UV2Cleared 510(K)
- K93466360 DEGREE FUNDUS CAMERA, CF-60UD2Cleared 510(K)
- K930442MARCO GXX SERIES PHOTOGRAPHIC SLIT LAMPS2Cleared 510(K)
- K923708LEMPERT OPTIC DISC ANALYSIS SYSTEM2Cleared 510(K)
- K923958CHROMOS IMAGER2Cleared 510(K)
- K913314CANDELA RETINAL CAMERA2Cleared 510(K)
- K913929DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEM2Cleared 510(K)
- K911439NON-MYDRIATIC RETINAL CAMERA, CR-45UAF2Cleared 510(K)
- K895474NON-MYDRIATIC RETINAL CAMERA, CR4-45NM DUAL2Cleared 510(K)
- K884989NEVISCAN MODEL N - 1002Cleared 510(K)
- K874355OPACITY LENSMETER 7012Cleared 510(K)
- K874017MODIFIED RETINAL CAMERA MODEL CR4-45NM2Cleared 510(K)
- K873157OXFORD RETRO-ILLUMINATION CATARACT CAMERA2Cleared 510(K)
- K862323CANON NON-MYDRIATIC RETINAL CAMERA CR4-45NM2Cleared 510(K)
- K855170CANON NON-MYDRIATIC RETINAL CAMERA CR3-45NM2Cleared 510(K)
- K854330IS-2000 DIGITAL OPHTHALMIC IMAGING SYSTEM2Cleared 510(K)
- K852638HUMPHREY IMAGE ANALYZER MODEL 1102Cleared 510(K)
- K843899GRC-WT, GRC-W2Cleared 510(K)
- K844898CANON 60 ZOOM FUNDUS CAMERA CF-60ZA OPHTHALMIC CAM2Cleared 510(K)
- K843021CANON 60 FUNDUS CAMERA CF-60U2Cleared 510(K)
- K833694TEXAS BIO SCAN2Cleared 510(K)
- K822991AO DOCUSTAR(MMIRO) FUNDUS CAMERA2Cleared 510(K)
- K823719AML (ANGLE MAGNIFYING LENS2Cleared 510(K)
- K822908COHERENT FUNDUSL RETINAL CAMERA2Cleared 510(K)
- K770888POMERANTZEFF EQUATOR PLUS CAMERA2Cleared 510(K)
- 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
Optomed Smartscope M5 with Optomed Smartscope FA
- Page Type
- Cleared 510(K)
- 510(k) Number
- K201325
- 510(k) Type
- Traditional
- Applicant
- Optomed Oyj
- Country
- Finland
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/20/2020
- Days to Decision
- 186 days
- Submission Type
- Summary