BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

    PMA: P180035 · Supplement: S001 · Decision Feb 5, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia
    Trade Name
    MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear
    PMA Number
    P180035
    Supplement Number
    S001
    Device Class
    FDA Class 3
    Product Code
    QIT
    Generic Name
    Daily wear soft contact lens to reduce the progression of myopia
    Medical Specialty
    Unknown
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 5, 2020
    Date Received
    November 29, 2019
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a repackaging/relabeling site located at CooperVision Manufacturing, Ltd., Mountpark, Unit 1, Wide Lane, Southampton, United Kingdom SO18 2NQ.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QIT Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia