BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Optego Vision USA, Inc.

    Reg #: 2085143 · FEI: 1000160574 · Expires 2026
    View on FDA
    Products
    31
    Proprietary Names
    40
    Establishment Types
    3
    Classifications
    31

    Registration Details

    Registration Name
    Optego Vision USA, Inc.
    Registration Number
    2085143
    FEI Number
    1000160574
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    4525 S. Coach Drive
    City
    Tucson
    State
    AZ
    ZIP
    85714
    Country
    US

    Regulatory Submissions

    510(k) Number
    K112832

    Owner / Operator

    Firm Name
    Optego Vision USA, Inc.
    Operator Number
    9044582
    Address
    4525 S. Coach Drive, --
    City
    Tucson
    State
    AZ
    Postal Code
    85714
    Country
    US
    Correspondent
    JOHAN T VAN DALEN

    Products

    Device Name Product Code
    Prism, Fresnel, Ophthalmic HKT
    Tape And Bandage, Adhesive KGX
    Caliper, Ophthalmic HOE
    Knife, Ophthalmic HNN
    Chart, Visual Acuity HOX
    Rack, Skiascopic HMH
    Curette, Ophthalmic HNZ
    Spectacle, Magnifying HOI
    Lens, Maddox HKR
    Strip, Schirmer KYD
    Dilator, Lachrymal HNW
    Specula, Ophthalmic HNC
    Frame, Trial, Ophthalmic HPA
    Spud, Ophthalmic HNA
    Pupillometer, Manual HLH
    Epilator, High Frequency, Needle-Type KCW
    Scissors, Ophthalmic HNF
    Dish, Tissue Culture KIZ
    Magnifier, Hand-Held, Low-Vision HJF
    Prism, Bar, Ophthalmic HKW
    Instrument, Measuring, Stereopsis HLC
    Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY
    Probe, Lachrymal HNL
    Instrument, Measuring, Lens, Ac-Powered HLM
    Instrument, Manual, Surgical, General Use MDM
    Set, Lens, Trial, Ophthalmic HPC
    Sunglasses (Non-Prescription Including Photosensitive) HQY
    Inserter/Remover Contact Lens KYE
    Case, Contact Lens LRX
    Simulatan (Including Crossed Cylinder) HOR
    Forceps, Ophthalmic HNR

    Proprietary Names

    Optego Fresnel Prism Optego Prism MASTER AID TAPE CALIPER Ophthalmic Knife EpiGlare School Bus Retinoscopy Rack CURETTE Magnifiers MADDOX Karickoff Strips Lacrimal Dilator SPECULA TRIAL SPUD PUPILLOMETER Pro Lectro Ophthalmic scissors DISH TISSUE CULTURE HAND-HELD MAGNIFIER LOW-VISION Loose Prism Block Worthmore Post Mydriatic Spectacles Clear Vented Eye Shields Eye Patch PROBE Lensometer Ophthalmic Instrument SUNGLASSES (NON-PRESCRIPTION) Contact Lens Removers Optego Contact Lens Case SIMULATAN (INCLUDIN ECC Jeweler's Forceps #4 ECC Jeweler's Forceps #1 ECC Jeweler's Forceps #7 ECC Jeweler's Forceps #5 ECC Jewelers Forceps #3

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device