BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OSIE-17-Symons OCT Image Enhancing Lens 17mm O.D.

    Reg #: 3014865 · FEI: 3014865 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    16
    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
    K863911

    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
    Lens, Contact, Polymethylmethacrylate, Diagnostic HJK

    Proprietary Names

    OSIE-17-Symons OCT Image Enhancing Lens 17mm O.D. OMRA-PRP-165-Mainster PRP 165 Laser Lens ORMR-1X-2-Reichel-Mainster 1x Retina Laser Lens NMR ORMR-1X-Reichel-Mainster 1x Retina Laser Lens OMRA-PRP-165-2-Mainster PRP 165 Laser Lens NMR OPR-120-ProRetina 120 PB Laser Lens OPDT-2-PDT 1.6x Laser Lens NMR ORMR-2X-Reichel-Mainster 2x Retina Laser Lens OMRA-S-2-Mainster Focal/Grid Laser Lens NMR OMRA-S-Mainster Focal/Grid Laser Lens OSIE-20-Symons OCT Image Enhancing Lens 20mm O.D. ORMR-1X-P-Pediatric Reichel-Mainster 1x Retina Laser Lens ORMR-2X-2-Reichel-Mainster 2x Retina Laser Lens NMR OPR-120-2-ProRetina 120 PB Laser Lens NMR OD-OS-Navilas Zero Power Laser Lens OPDT-PDT 1.6x Laser Lens

    Establishment Types

    Manufacture Medical Device