Recall Z-2647-2014— 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: 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.. 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
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.
Reason for recall
Marketing without marketing clearance or approval.
Data sourced from openFDA. This site is unofficial and independent of the FDA.