BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Essilor Laboratories of America, Inc. dba Omega Northcreek Lab

    Reg #: 3038269608 · FEI: 3038269608 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Essilor Laboratories of America, Inc. dba Omega Northcreek Lab
    Registration Number
    3038269608
    FEI Number
    3038269608
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    13675 N Stemmons Fwy
    City
    Dallas
    State
    TX
    ZIP
    75234
    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 (Prescription), For Reading Discomfort NJH
    Prescription Spectacle Lenses To Reduce The Progression Of Myopia QUR

    Proprietary Names

    Presio i Approval Essilor Stellest, Essilor Stellest Glasses

    Establishment Types

    Manufacture Medical Device