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.
This recall has been terminated (originally issued September 16, 2014).
- Company
- Advanced Photonic Systems, Llc
- Recall Initiated
- May 6, 2014
- Posted
- September 16, 2014
- Terminated
- June 24, 2015
- Recall Number
- Z-2646-2014
- Quantity
- 235 Total
- Firm Location
- Cocoa Beach, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Marketing without marketing clearance or approval.
Distribution
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 / Code Info
Model 150
Root Cause
No Marketing Application
Action Taken
Advanced Photonic Systems sent an Urgent Medical Device Recall letter dated July 12, 2014 via UPS to all those who are known by APS to have possession, custody, or control of the affected device. Customers were instructed to return the recalled product at the sole expense of APS. Each 90 days for the following year, APS plans to provide a progress report to the FDA that identifies which recipients have complied. For more information , customers may write to Advanced Photonic Systems, LLC at the address provided or call 1-800-210-5060 (9am to 5pm, Monday through Friday). For questions regarding this recall call 800-210-5060.