BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇺🇸 United States

    Valeda Light Delivery System

    K Number: DEN230083 · Decision Nov 4, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    326

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    Basic Information

    Device Name
    Valeda Light Delivery System
    K Number
    DEN230083
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    886.5520
    Medical Specialty
    Ophthalmic
    Decision
    Unknown
    Applicant
    Lumithera, Inc.
    Date Received
    December 14, 2023
    Decision Date
    November 4, 2024
    Product Code
    SDE
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    SDE Light Based Device For Dry Age-Related Macular Degeneration