BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GENTEX OPTICS, INC.

    Reg #: 1215866 · FEI: 1215866 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    17
    Establishment Types
    1
    Classifications
    2

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    Registration Details

    Registration Name
    GENTEX OPTICS, INC.
    Registration Number
    1215866
    FEI Number
    1215866
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    183 WEST MAIN ST.
    City
    DUDLEY
    State
    MA
    ZIP
    01571
    Country
    US

    Regulatory Submissions

    510(k) Number
    DEN250016

    Owner / Operator

    Firm Name
    Essilor of America, Inc
    Operator Number
    8010073
    Address
    13515 N Stemmons Fwy
    City
    Dallas
    State
    TX
    Postal Code
    75234
    Country
    US

    Products

    Device Name Product Code
    Lens, Spectacle, Non-Custom (Prescription) HQG
    Prescription Spectacle Lenses To Reduce The Progression Of Myopia QUR

    Proprietary Names

    Small Fit Ovation Varilux Xperio Trivex Presio i Approval Kodak Avance TruClear DEFINITY 2 Definity VARILUX-2 Crizal Sharpview Essilor Ideal Optifog Essilor Stellest, Essilor Stellest Glasses

    Establishment Types

    Manufacture Medical Device