Recall Z-2646-2014 ยท OLI Fat Reducing Low Level Laser
Advanced Photonic Systems, LLC
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, wrink
| Date | Sep 16, 2014 (initiated May 6, 2014) |
| Status | Terminated |
| Reason | Marketing without marketing clearance or approval. |
| Root cause | No Marketing Application |
| Action | 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 regardin |
| Quantity | 235 Total |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.