BEUDAMED
    FDA Enforcement Class II Ongoing

    Non-ablative Fractional Laser Systems, Model: WFB-01

    Recall: Z-0555-2025 · Reported December 11, 2024

    Enforcement

    Recall Number
    Z-0555-2025
    Event ID
    95831
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    WINGDERM ELECTRO-OPTICS LTD.
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    December 11, 2024
    Initiation Date
    August 23, 2024
    Classification Date
    December 5, 2024
    Address
    Room 312, Building D-3, Dongsheng Science Park, No.66 Of Xixiaokou Road, Haidian District, Beijing, N/A, China

    Description

    Non-ablative Fractional Laser Systems, Model: WFB-01

    Reason

    Model WFB-01 sold to US customers before Aug 23, 2022 has been found to have a software bug (6 units). All WFB-01 models sold to US customers found to have labeling non-compliances (22 units)

    Code Info

    F7201110001 F1210910001 F1210910002 F7211210001 F7226110002 F7227110001

    Distribution

    Worldwide Distribution