BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P160055 · Supplement: S015 · Decision Apr 20, 2021
    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
    RxSight Light Adjustable Lens and Light Delivery Device
    PMA Number
    P160055
    Supplement Number
    S015
    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
    April 20, 2021
    Date Received
    October 22, 2020
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for (1) a simplified fixed output beam aperture in place of the current motorized aperture, (2) update to LDD lock-in treatment profile to reduce ocular exposure, (3) update to the Windows 10 operating system, (4) extension of dioptric power range to include +4.0 to +9.0 diopters, (5) introduce an additional UV-A absorber to the anterior portion of the LAL, and (6) updates to manufacturing work instructions, LDD Graphical User Interface (GUI), and user labeling to reflect all modifications.

    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)