FDAFDA · Food and drugs·Recall number Z-2647-2014
Photonica Light Modulator. 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.
Published September 24, 2014 · Recall initiated: May 6, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Marketing without marketing clearance or approval.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Advanced Photonic Systems, LLC
- Distributor
- 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
- Lot
- Models ULT-1, TDR-1, and TDR-2
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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