BEUDAMED
    FDA Registration Active 🇺🇸 United States

    O2M-Two Mirror Gonio Diagnostic Lens

    Reg #: 3014865 · FEI: 3014865 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    OCULAR INSTRUMENTS, INC.
    Registration Number
    3014865
    FEI Number
    3014865
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2255 116TH AVE., N.E.
    City
    BELLEVUE
    State
    WA
    ZIP
    98004
    Country
    US

    Regulatory Submissions

    510(k) Number
    K895846

    Owner / Operator

    Firm Name
    OCULAR INSTRUMENTS
    Operator Number
    3014865
    Address
    2255 116TH AVE. N.E., --
    City
    Bellevue
    State
    WA
    Postal Code
    98004
    Country
    US
    Correspondent
    Staci D Caldwell

    Products

    Device Name Product Code
    Prism, Gonioscopic HKS

    Proprietary Names

    O2M-Two Mirror Gonio Diagnostic Lens O2MF-Two Mirror Gonio Diagnostic Lens w/Flange O2MA-2-Two Mirror Gonio Laser Lens NMR-Kapetensky O2MFA-Two Mirror Gonio Laser Lens w/ Flange O2M-2-Two Mirror Gonio Diagnostic Lens NMR-Kapetensky O2MA-Two Mirror Gonio Laser Lens

    Establishment Types

    Manufacture Medical Device