BEUDAMED
    FDA Enforcement Class II Ongoing

    N-LHP-928, HeNe Laser System, 35 mW

    Recall: Z-2977-2024 · Reported September 18, 2024

    Enforcement

    Recall Number
    Z-2977-2024
    Event ID
    95290
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    PACIFIC LASERTECH, LLC
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    September 18, 2024
    Initiation Date
    March 1, 2024
    Classification Date
    September 10, 2024
    Address
    215 Bingham Dr # 110, San Marcos, CA, 92069-1403, United States

    Description

    N-LHP-928, HeNe Laser System, 35 mW

    Reason

    These laser products fail to comply with 21 CFR 1040.10(f)(4) Key control which requires, Each laser system classified as a Class IIIb or IV laser product shall incorporate a key-actuated master control. The key shall be removable and the laser shall not be operable when the key is removed. , because while the laser is switched on, the key can be removed from the key switch. The correction is replacement with a key switch that captures the key when in the on position.

    Code Info

    N-LHP-928

    Distribution

    US Nationwide Distribution

    Quantity

    32