BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇺🇸 United States

    Essilor® Stellest®

    K Number: DEN250016 · Decision Sep 25, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    150

    Basic Information

    Device Name
    Essilor® Stellest®
    K Number
    DEN250016
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    886.5845
    Medical Specialty
    Ophthalmic
    Decision
    Unknown
    Applicant
    Essilor Of America, Inc.
    Date Received
    April 28, 2025
    Decision Date
    September 25, 2025
    Product Code
    QUR
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QUR Prescription Spectacle Lenses To Reduce The Progression Of Myopia