BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P160055 · Decision Nov 22, 2017
    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
    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, 2017
    Date Received
    December 9, 2016
    Expedited Review
    N
    Docket Number
    17M-6614

    Advisory Committee Statement

    Approval for The Light Adjustable Lens and Light Delivery Device system is indicated for the reduction residual astigmatism to improve uncorrected visual acuity after removal of the cataractous natural lens by phacoemulsification and implantation of the intraocular lens in the capsular bag, in adult patients: 1) With pre-existing corneal astigmatism of => 0.75 diopters; and 2) Without pre-existing macular disease. The system also reduces the likelihood of clinically significant residual spherical refractive errors.

    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)