Recall Z-2645-2014— Advanced Photonic Systems, LLC
Class II · Terminated
Class II FDA medical device recall by Advanced Photonic Systems, LLC, initiated 2014-05-06, terminated 2015-06-24. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Marketing without marketing clearance or approval..
- Recalling firm
- Advanced Photonic Systems, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-05-06
- Terminated
- 2015-06-24
- Firm location
- Cocoa Beach, FL, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.