BEUDAMED
    FDA Enforcement Class II Terminated

    Ultraslim. These include all products labeled as UltraSlim, Luxurian, BioSlim Lipo, Cellulize, Slim 'n Trim, UltraRed, UltraBlue, Slim-PRO, Dazzle Light, UltraSlim Cold Light, SlenderRay, and U-Slim It, as well as those products with private labelling branding. Company claims that the program combines detoxification, red light exposure, hydration, full body vibration, massage, Niacin, Milk Thistle, and the use of compression garments. Sensible diet and exercise are recommended, but not required.

    Recall: Z-2645-2014 · Reported September 24, 2014

    Enforcement

    Recall Number
    Z-2645-2014
    Event ID
    69117
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Advanced Photonic Systems, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 24, 2014
    Initiation Date
    May 6, 2014
    Classification Date
    September 16, 2014
    Termination Date
    June 24, 2015
    Address
    1980 N Atlantic Ave, Suite 930, Cocoa Beach, FL, 32931-5213, United States

    Description

    Ultraslim. These include all products labeled as UltraSlim, Luxurian, BioSlim Lipo, Cellulize, Slim 'n Trim, UltraRed, UltraBlue, Slim-PRO, Dazzle Light, UltraSlim Cold Light, SlenderRay, and U-Slim It, as well as those products with private labelling branding. Company claims that the program combines detoxification, red light exposure, hydration, full body vibration, massage, Niacin, Milk Thistle, and the use of compression garments. Sensible diet and exercise are recommended, but not required.

    Reason

    Marketing without marketing clearance or approval.

    Code Info

    Models BR-144, BRS-144 and BRC-144

    Distribution

    Worldwide Distribution - US- AL, AZ, CA, CO, FL, GA, ID, IL, IN, LA, MA, MD, MI, MN, MO, NV, NJ, NY, NC, OH, PA, TX, UT, and VA. Internationally to Canada, France, and Switzerland

    Quantity

    235 Total