BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

    PMA: P180035 · Supplement: S020 · Decision Jul 10, 2024
    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
    S020
    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
    July 10, 2024
    Date Received
    April 16, 2024
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    Approval of the revised protocol for the MiSight 1 Day Safety post-approval study (PAS)

    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