BEUDAMED
    FDA Recall Terminated

    Luxurian. 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-2646-2014 · Initiated May 6, 2014

    Recall

    Recall Number
    Z-2646-2014
    Event Number
    69117
    Firm
    Advanced Photonic Systems, LLC
    FEI Number
    3010053203
    Product Code
    OLI
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    May 6, 2014
    Posted
    September 16, 2014
    Terminated
    June 24, 2015
    Address
    1980 N Atlantic Ave, Suite 930, Cocoa Beach, FL, 32931-5213

    Description

    Luxurian. 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.

    Action

    Advanced Photonic Systems sent an Urgent Medical Device Recall letter dated July 12, 2014 via UPS to all those who are known by APS to have possession, custody, or control of the affected device. Customers were instructed to return the recalled product at the sole expense of APS. Each 90 days for the following year, APS plans to provide a progress report to the FDA that identifies which recipients have complied. For more information , customers may write to Advanced Photonic Systems, LLC at the address provided or call 1-800-210-5060 (9am to 5pm, Monday through Friday). For questions regarding this recall call 800-210-5060.

    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