BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Disposable Capsulotomy (VCAPSD)

    Reg #: 1528142 · FEI: 1000122772 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    VOLK OPTICAL INC.
    Registration Number
    1528142
    FEI Number
    1000122772
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    7893 ENTERPRISE DR.
    City
    Mentor
    State
    OH
    ZIP
    44060
    Country
    US

    Regulatory Submissions

    510(k) Number
    K151961

    Owner / Operator

    Firm Name
    VOLK OPTICAL INC.
    Operator Number
    9000705
    Address
    7893 ENTERPRISE DR.
    City
    Mentor
    State
    OH
    Postal Code
    44060
    Country
    US
    Correspondent
    Peter Chen

    Products

    Device Name Product Code
    Lens, Contact, Polymethylmethacrylate, Diagnostic HJK

    Proprietary Names

    Disposable Capsulotomy (VCAPSD) Disposable Iridotomy (VIRIDD) Disposable Capsulotomy Box of 400 (VCAPSD400) Disposable Iridotomy Box of 10 (VIRIDD10) Disposable Iridotomy Box of 100 (VIRIDD100) Disposable Capsulotomy Box of 100 (VCAPSD100) Disposable Iridotomy Box of 400 (VIRIDD400) Disposable Capsulotomy Box of 10 (VCAPSD10)

    Establishment Types

    Manufacture Medical Device