BEUDAMED
    FDA Enforcement Class II Terminated

    Photonica Light Modulator. 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 product provide non-invasive solutions to improve the appearance of fat accumulations, cellulite, fine lines, wrinkles, skin tone, and blemishes.

    Recall: Z-2647-2014 · Reported September 24, 2014

    Enforcement

    Recall Number
    Z-2647-2014
    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

    Photonica Light Modulator. 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 product provide non-invasive solutions to improve the appearance of fat accumulations, cellulite, fine lines, wrinkles, skin tone, and blemishes.

    Reason

    Marketing without marketing clearance or approval.

    Code Info

    Models ULT-1, TDR-1, and TDR-2

    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