BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Disposable Direct Image WideField (VWFD)

    Reg #: 1528142 · FEI: 1000122772 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    28
    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
    K050623

    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 Direct Image WideField (VWFD) Disposable Direct Image 30 Prism (V30PD) Disposable Direct Image Flat SSV (VFLATSSVD) Disposable Direct Image BiConcave (VBCD) Disposable Direct Image Flat (VFD) Disposable Direct Image 1.5x Mag (VMD) Disposable Direct Image 30 Prism Box of 100 (V30PD100) Disposable Direct Image BiConcave Box of 10 (VBCD10) Disposable Direct Image WideField Box of 100 (VWFD100) Disposable Direct Image 1.5x Mag Box of 100 (VMD100) Disposable Direct Image Flat SSV Box of 10 (VFLATSSVD10) Disposable Direct Image Flat SSV Box of 100 (VFLATSSVD100) Disposable Direct Image Flat Box of 10 (VFD10) Disposable Direct Image 30 Prism Box of 10 (V30PD10) Disposable Direct Image WideField Box of 10 (VWFD10) Disposable Direct Image Flat Box of 800 (VFD800) Disposable Direct Image 30 Prism Box of 800 (V30PD800) Disposable Direct Image WideField Box of 800 (VWFD800) Disposable Direct Image BiConcave Box of 100 (VBCD100) Disposable Direct Image BiConcave Box of 800 (VBCD800) Disposable Direct Image Flat SSV Box of 800 (VFLATSSVD800) Disposable Direct Image Flat Box of 100 (VFD100) Disposable Direct Image 1.5x Mag Box of 10 (VMD10) Disposable Direct Image 1.5x Mag Box of 800 (VMD800) Single Use Indirect Wide Field (VVITSSVDH) Single Use Indirect Wide Field Box of 100 (VVITSSVDH100) Single Use Indirect Wide Field Box of 10 (VVITSSVDH10) Single Use Indirect Wide Field Box of 400 (VVITSSVDH400)

    Establishment Types

    Manufacture Medical Device