BEUDAMED
    FDA Enforcement Class II Ongoing

    Class IV New Era medical laser device

    Recall: Z-0440-2021 · Reported November 25, 2020

    Enforcement

    Recall Number
    Z-0440-2021
    Event ID
    86706
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Inova Lasers LLC
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    November 25, 2020
    Initiation Date
    January 29, 2020
    Classification Date
    November 17, 2020
    Address
    433 5th Ave Fl 6, N/A, New York, NY, 10016-2207, United States

    Description

    Class IV New Era medical laser device

    Reason

    The firm failed to comply with the applicable standards regarding Electronic Product Radiation Control (EPRC) regulations associated with the laser product performance standard and certification.

    Code Info

    New Era laser units

    Distribution

    US Nationwide Distribution

    Quantity

    8 units