BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ART OPTICAL CONTACT LENS, INC.

    Reg #: 1835957 · FEI: 3002340631 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    39
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    ART OPTICAL CONTACT LENS, INC.
    Registration Number
    1835957
    FEI Number
    3002340631
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3175 3 MILE RD. NW
    City
    Walker
    State
    MI
    ZIP
    49534
    Country
    US

    Regulatory Submissions

    510(k) Number
    K073621

    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 (Other Material) - Daily HQD
    Lens, Contact (Orthokeratology) MUW
    Lenses, Soft Contact, Daily Wear LPL
    Lens, Contact (Rigid Gas Permeable), Extended Wear MWL
    Lens, Contact (Polymethylmethacrylate) HPX

    Proprietary Names

    Optimum Extra W/THP Optimum Extreme W/THP Optimum Comfort W/THP TYRO 97 w/THP Acuity 100 w/THP Boston ES Boston ES Multivision Boston XO Boston XO2 Optimum Extra Optimum Extreme Optimum Classic Optimum Comfort Acuity 18 HEXA100 Boston EO Acuity 100 Optimum Infinite FLOSI Boston XO w/THP Boston EO w/THP Boston ES w/THP Boston XO2 w/THP Menicon Z Acuity 200 w/THP Equalens II Intelliwave SA-32 SA-18 EQII Equalens Acuity 58 Boston II Boston IV Acuity 200 Tyro-97 ONSI-56 Kerasoft IC Onsi-56

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device