BEUDAMED
    FDA Enforcement Class II Terminated

    Denlase: Diode Laser Therapy System and Penlase: Dental Laser Therapy System surgical powered. Surgical powered Laser instruments.

    Recall: Z-1145-2014 · Reported March 26, 2014

    Enforcement

    Recall Number
    Z-1145-2014
    Event ID
    67520
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    China Daheng Group Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    March 26, 2014
    Initiation Date
    July 15, 2013
    Classification Date
    March 14, 2014
    Termination Date
    April 17, 2015
    Address
    #A9 Shangdi Xinxilu, Haidian District, Beijing, N/A, China

    Description

    Denlase: Diode Laser Therapy System and Penlase: Dental Laser Therapy System surgical powered. Surgical powered Laser instruments.

    Reason

    Failure to provide calibration procedures to purchasers, as required by 21 CFR 1040.11(a)(2). For example, the user manual did not contain calibration procedures for Denlase or Penlase Lasers

    Code Info

    Denlase and Penlase Dental Laser Systems.

    Distribution

    CA, KS, IL, PA, NJ, WI, WY, KY, FL and NY India, Indonesia, Turkey, Denmark, and France,

    Quantity

    238