BEUDAMED
    FDA Recall Open, Classified

    Diode Laser Hair Removal model: WLA-01

    Recall: Z-0556-2025 · Initiated August 23, 2024

    Recall

    Recall Number
    Z-0556-2025
    Event Number
    95831
    Firm
    WINGDERM ELECTRO-OPTICS LTD. Room 312 Building D-3, Dongsheng Science Park, No.66 Of Xixiaokou Road, Haidian District Beijing China
    FEI Number
    3014310779
    Product Code
    GEX
    Status
    Open, Classified
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    August 23, 2024
    Posted
    December 5, 2024

    Description

    Diode Laser Hair Removal model: WLA-01

    Reason

    All model WLA-01 systems sold to US customers are found to have labeling non-compliances

    Action

    The firm sent a notification letter to the relevant distribution on June 6, 2024. Products sold before August 23, 2022, will require a software version upgrade to F1-B-1.1.012 or Higher.

    Distribution

    Worldwide Distribution