BEUDAMED
    FDA Enforcement Class II Terminated

    All brochures printed before November 20, 2013 for the HyperBlue 1530 medical laser, including the product brochure and the online information regarding the product at www.hyperionMed.com before December 3, 2013.

    Recall: Z-2264-2014 · Reported August 27, 2014

    Enforcement

    Recall Number
    Z-2264-2014
    Event ID
    67814
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hyperion Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 27, 2014
    Initiation Date
    November 20, 2013
    Classification Date
    August 18, 2014
    Termination Date
    May 15, 2015
    Address
    15914 Midway Rd, Addison, TX, 75001-4261, United States

    Description

    All brochures printed before November 20, 2013 for the HyperBlue 1530 medical laser, including the product brochure and the online information regarding the product at www.hyperionMed.com before December 3, 2013.

    Reason

    Brochures and web site information for the HyperBlue 1530 diode laser promoted features which had not been cleared in the product's premarket notification to the FDA. The web site and brochures had claims that it could use 940 nm, 808 nm, and 532 nm wavelengths as single wavelengths or in combination with other wavelengths, and a claim that the product could be used with a 15 mm hand piece.

    Code Info

    All brochures and online literature printed before November 20, 2013.

    Distribution

    US Distribution including the states of PA, MD, UT, TX, OH, GA, MO, FL, CO, and WA.

    Quantity

    3,346 brochures. Quantity not applicable to web site.