BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

    PMA: P180035 · Decision Nov 15, 2019
    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
    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
    November 15, 2019
    Date Received
    September 4, 2018
    Expedited Review
    N
    Docket Number
    19M-5438

    Advisory Committee Statement

    Approval for MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear. This device indicated for the correction of myopic ametropia and for slowing the progression of myopia in children with non-diseased eyes, who at the initiation of treatment are 8-12 years of age and have a refraction of -0.75 to -4.00 diopters (spherical equivalent) with less than or equal to 0.75 diopters of astigmatism. The lens is to be discarded after each removal.

    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