Z-2645-2014 Class II Terminated
FDA device recall Z-2645-2014 was initiated by Advanced Photonic Systems, LLC on May 6, 2014 and is designated Class II. Reason for recall: Marketing without marketing clearance or approval. The recall status is terminated (terminated June 24, 2015). Affected quantity: 235 Total.
Recall Details
- Product Type
- Devices
- Report Date
- September 24, 2014
- Initiation Date
- May 6, 2014
- Termination Date
- June 24, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 235 Total
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.
Reason for Recall
Marketing without marketing clearance or approval.
Distribution Pattern
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
Code Information
Models BR-144, BRS-144 and BRC-144