BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lenses, Soft Contact, Extended Wear

    PMA: P080011 · Supplement: S180 · Decision Jul 23, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

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    Basic Information

    Device Name
    Lenses, Soft Contact, Extended Wear
    Trade Name
    up&up Monthly Performance, up&up Monthly Performance XR, up&up Monthly Performance for Astigmatism, up&up Monthly Perfor
    PMA Number
    P080011
    Supplement Number
    S180
    Device Class
    FDA Class 3
    Product Code
    LPM
    Generic Name
    Lenses, soft contact, extended wear
    Regulation Number
    886.5925
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 23, 2025
    Date Received
    January 27, 2025
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for trade name change for CooperVision comfilcon A soft (hydrophilic) contact lenses for extended wear to add up&up Monthly Performance (intended for the spherical lens design), up&up Monthly Performance XR (intended for the extended range “XR” powers of the spherical lens design), up&up Monthly Performance for Astigmatism (intended for the toric lens design), and up&up Monthly Performance Multifocal (intended for the multifocal lens design)

    Classifications

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

    Product Code Device Name
    LPM Lenses, Soft Contact, Extended Wear