BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

    PMA: P180035 · Supplement: S010 · Decision Sep 15, 2022
    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)
    PMA Number
    P180035
    Supplement Number
    S010
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    September 15, 2022
    Date Received
    August 17, 2022
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Manufacture of MiSight 1 Day product on Dry Line HE and Wet Line HVE at the CooperVision Warrior Close manufacturing facility in Chandlers Ford, Eastleigh, UK.

    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