BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P160055 · Supplement: S008 · Decision Nov 22, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    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
    S008
    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
    November 22, 2019
    Date Received
    September 13, 2019
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for additional qualified coupling agents and UV protective eyewear to be used with the LAL/LDD.

    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)