BEUDAMED
    FDA Enforcement Class II Terminated

    DermaPen Pro Model, Micro Needling System, a motorized AC powered surgical instrument for dermabrasive use. Each motorized handpiece is packaged within a small box. Each disposable needle cartridge is packaged individually and then placed into boxes of 30 quantities per box.

    Recall: Z-2740-2015 · Reported September 16, 2015

    Enforcement

    Recall Number
    Z-2740-2015
    Event ID
    71149
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Derma Pen, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 16, 2015
    Initiation Date
    February 5, 2015
    Classification Date
    September 5, 2015
    Termination Date
    January 31, 2017
    Address
    3216 Highland Dr Suite 200, N/A, Salt Lake City, UT, 84106-4178, United States

    Description

    DermaPen Pro Model, Micro Needling System, a motorized AC powered surgical instrument for dermabrasive use. Each motorized handpiece is packaged within a small box. Each disposable needle cartridge is packaged individually and then placed into boxes of 30 quantities per box.

    Reason

    Derma Pen initiated a field communication for Dermapen after receiving an FDA warning letter for distributing a device without FDA clearance or approval.

    Code Info

    All devices on the market

    Distribution

    Worldwide Distribution - US (nationwide) Distribution including Puerto Rico and The Virgin Islands and to the countries of : Canada, Brazil, Colombia, Ecuador, Costa Rica, Australia, Hong Kong, Netherlands, Mexico, Romania, Sweden, Peru, Greece, United Kingdom and United Arab Emirates.

    Quantity

    1,466 units