BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P160055 · Supplement: S055 · Decision Jun 8, 2026
    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
    RxSight Light Adjustable Lens; Light Delivery Device
    PMA Number
    P160055
    Supplement Number
    S055
    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
    June 8, 2026
    Date Received
    April 17, 2026
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    approval for a change in the routine Ethylene Oxide sterilization process parameters, specifically a reduction in the Ethylene Oxide gas concentration used to terminally sterilize the subject devices

    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)