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Recall Observatory FDA recall evidence

Device product

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.

Z-2645-2014

May 06, 2014

Class II

Product summary

Firm
Advanced Photonic Systems, LLC
Event
Event 69117
Status
Terminated
Classification
Class II
Quantity
235 Total
Official record key
device-enforcement:Z-2645-2014

Official wording

Reason: Marketing without marketing clearance or approval.

Code information: Models BR-144, BRS-144 and BRC-144

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketing without marketing clearance or approval.