BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

    PMA: P180035 · Supplement: S031 · Decision Oct 28, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    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
    S031
    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
    October 28, 2025
    Date Received
    August 27, 2025
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    Approval of protocol changes to enroll approximately 1000 subjects in PAS002 to achieve at least 4000 patient years total (approximately 2000 per study) with an average follow up of 2-3 years per subject. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P180035.

    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