Device product
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.
Z-2646-2014
Product summary
- Event
- Event 69117
- Status
- Terminated
- Classification
- Class II
- Quantity
- 235 Total
- Official record key
device-enforcement:Z-2646-2014
Official wording
Reason: Marketing without marketing clearance or approval.
Code information: Model 150
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
Marketing without marketing clearance or approval.