BEUDAMED
    FDA Enforcement Class II Terminated

    miraDry System consisting of the MD4000-MC Console, the MD4000-HP miraDry Handpiece, and the MD4000-BT miraDry bioTip and accessories. General and Plastic Surgery: The miraDry System is intended for the treatment of primary axillary hyperhidrosis and was recently cleared for the permanent removal of underarm hair.

    Recall: Z-0234-2016 · Reported November 18, 2015

    Enforcement

    Recall Number
    Z-0234-2016
    Event ID
    72386
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Miramar Labs, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 18, 2015
    Initiation Date
    October 9, 2015
    Classification Date
    November 6, 2015
    Termination Date
    December 23, 2015
    Address
    2790 Walsh Ave, N/A, Santa Clara, CA, 95051-0963, United States

    Description

    miraDry System consisting of the MD4000-MC Console, the MD4000-HP miraDry Handpiece, and the MD4000-BT miraDry bioTip and accessories. General and Plastic Surgery: The miraDry System is intended for the treatment of primary axillary hyperhidrosis and was recently cleared for the permanent removal of underarm hair.

    Reason

    Update to labeling for the miraDry Console to remind users to only use approved lubricants in a thin layer to prevent potential burns and blisters.

    Code Info

    MN-MD4000-MC, all units

    Distribution

    Nationwide Distribution

    Quantity

    277 units