BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lens, Contact, Orthokeratology, Overnight

    PMA: P990018 · Supplement: S006 · Decision May 6, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14

    Basic Information

    Device Name
    Lens, Contact, Orthokeratology, Overnight
    Trade Name
    ACUVUE® Abiliti™ Overnight and ACUVUE® Abiliti™ Overnight Therapeutic Lenses for Myopia Management
    PMA Number
    P990018
    Supplement Number
    S006
    Device Class
    FDA Class 3
    Product Code
    NUU
    Generic Name
    Lens, contact, orthokeratology, overnight
    Regulation Number
    886.5916
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 6, 2021
    Date Received
    January 21, 2021
    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 addition of the following private label trade names for the Menicon Z Night (tisilfocon A) Contact Lenses for Overnight Wear: ACUVUE® Abiliti Overnight and ACUVUE® Abiliti Overnight Therapeutic Lenses for Myopia Management.

    Classifications

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

    Product Code Device Name
    NUU Lens, Contact, Orthokeratology, Overnight