BEUDAMED
    FDA Enforcement Class II Ongoing

    Beijing Syntech Laser UL C02 Laser surgical lasers

    Recall: Z-1491-2018 · Reported May 9, 2018

    Enforcement

    Recall Number
    Z-1491-2018
    Event ID
    79697
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Beijing Syntech Laser Co., Ltd
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    May 9, 2018
    Initiation Date
    July 3, 2017
    Classification Date
    May 2, 2018
    Address
    International Industry Base, West Area F/4; No. 8 Liye Road; Changping, Beijing, N/A, N/A, China

    Description

    Beijing Syntech Laser UL C02 Laser surgical lasers

    Reason

    The noncompliance is that the certification label was not affixed on the product, with statement "Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007".

    Code Info

    Model UL C02 Laser

    Distribution

    US Distribution

    Quantity

    92