BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

    PMA: P160055 · Supplement: S045 · Decision Sep 2, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)
    Trade Name
    LIGHT ADJUSTABLE LENS (LAL) AND LIGHT DELIVERY DEVICE (LDD)
    PMA Number
    P160055
    Supplement Number
    S045
    Device Class
    FDA Class 3
    Product Code
    PZK
    Generic Name
    Light adjustable lens (LAL) and light delivery device (LDD)
    Regulation Number
    886.3600
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 2, 2025
    Date Received
    March 7, 2025
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - PAS
    Expedited Review
    N

    Advisory Committee Statement

    approval for the professional and patient labeling to include the outcomes of the Post-approval study (PAS) LAL/LDD Postmarket RCT

    Classifications

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

    Product Code Device Name
    PZK Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)