BEUDAMED
    FDA Recall Open, Classified

    Smaxel Fractional CO2 Laser, a Class IV medical laser system.

    Recall: Z-0804-2025 · Initiated October 16, 2024

    Recall

    Recall Number
    Z-0804-2025
    Event Number
    96034
    Firm
    IDS LTD 194 Simgung-Ro Gwangtan-Myeon Paju Korea (the Republic of)
    FEI Number
    3012639861
    Product Code
    ONG
    Status
    Open, Classified
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    October 16, 2024
    Posted
    January 7, 2025

    Description

    Smaxel Fractional CO2 Laser, a Class IV medical laser system.

    Reason

    The Smaxel Fractional CO2 Laser does not include a Certification label, and adequate instructions for safe operation of the device.

    Action

    IDS LTD recommend that users are advised to use it as close to the main body as possible during the procedure. The firm will without charge remedy the defect or bring the product into compliance with each applicable Federal standard. On or about 1/22/2025, the firm mailed a "Notification Letter" to affected customers/users informing them that the SAXEL Fractional CO2 Laser System does not have affixed a certification label and that the firm will be implementing a design change by revising the certification label and will provide the revised certification label free of charge following the design change.

    Distribution

    Worldwide - US Nationwide Distribution

    Quantity

    23