BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Optimum Extreme

    Reg #: 1835957 · FEI: 3002340631 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ART OPTICAL CONTACT LENS, INC.
    Registration Number
    1835957
    FEI Number
    3002340631
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3175 3 MILE RD. NW
    City
    Walker
    State
    MI
    ZIP
    49534
    Country
    US

    Regulatory Submissions

    510(k) Number
    K160859

    Owner / Operator

    Firm Name
    ART OPTICAL CONTACT LENS, INC.
    Operator Number
    9034824
    Address
    3175 THREE MILE RD. NW, --
    City
    Walker
    State
    MI
    Postal Code
    49534
    Country
    US
    Correspondent
    Erik Anderson

    Products

    Device Name Product Code
    Lens, Contact (Orthokeratology) MUW

    Proprietary Names

    Optimum Extreme Optimum Extra

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)