BEUDAMED
    FDA Enforcement Class II Terminated

    FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures.

    Recall: Z-1463-2014 · Reported April 23, 2014

    Enforcement

    Recall Number
    Z-1463-2014
    Event ID
    67835
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Solta Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 23, 2014
    Initiation Date
    March 20, 2014
    Classification Date
    April 16, 2014
    Termination Date
    April 27, 2015
    Address
    25881 Industrial Blvd, N/A, Hayward, CA, 94545-2991, United States

    Description

    FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures.

    Reason

    Obsolete versions of the Laser Treatment Settings card for the Fraxel DUAL 1550/1927 Laser system may have contained incorrect indication for use for treatment of Melasma.

    Code Info

    Model MC-SYS-SR1500-D, Revisions A and B.

    Distribution

    Worldwide distribution

    Quantity

    1077 units