BEUDAMED
    FDA Enforcement Class II Terminated

    Candela Laser GentleLase Pro, Powered Laser Surgical Instrument for dermatological use - Model number: 9914-00-9015. and Candela Laser GentleLase Pro LE, Model number: 9914-00-9040

    Recall: Z-0348-2014 · Reported November 27, 2013

    Enforcement

    Recall Number
    Z-0348-2014
    Event ID
    66773
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Candela Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 27, 2013
    Initiation Date
    November 6, 2013
    Classification Date
    November 18, 2013
    Termination Date
    June 8, 2015
    Address
    530 Boston Post Rd, Wayland, MA, 01778-1833, United States

    Description

    Candela Laser GentleLase Pro, Powered Laser Surgical Instrument for dermatological use - Model number: 9914-00-9015. and Candela Laser GentleLase Pro LE, Model number: 9914-00-9040

    Reason

    Unintended single pulse maybe emitted to handpiece prior to pressing of trigger or footswitch and cause injury.

    Code Info

    GL Pro Model 9914-00-9015:: SN 9914-9015-0005 through 9914-9015-1259 GL Pro LE Model 9914-00-9040: SN 9914-9040-0716 through 9914-9040-1214

    Distribution

    Worldwide distribution: US (nationwide) and Internationally to: Azerbaijan, Bulgaria, Chile, Czech Republic, Greece, Israel, Kuwait, Qatar, Saudi Arabia, Serbia, Turkey, and the United Arab Emirates and to Subsidiaries in Australia, France, Germany, Italy, Japan, Portugal, Spain, and the United Kingdom.

    Quantity

    1258 units