Events

Recall of Device Recall UltraSlim

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Advanced Photonic Systems, LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    69117
  • Event Risk Class
    Class 2
  • Event Number
    Z-2645-2014
  • Event Initiated Date
    2014-05-06
  • Event Date Posted
    2014-09-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-06-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129668
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Fat reducing low level laser - Product Code OLI
  • 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.

Device

Device Recall UltraSlim
  • Model / Serial
    Models BR-144, BRS-144 and BRC-144
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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
  • Product 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.
  • Manufacturer
    Advanced Photonic Systems, LLC

Manufacturer

Advanced Photonic Systems, LLC
  • Manufacturer Address
    Advanced Photonic Systems, LLC, 1980 N Atlantic Ave, Suite 930, Cocoa Beach FL 32931-5213
  • Manufacturer Parent Company (2017)
    Advanced Photonic Systems Llc
  • Source
    USFDA