Z-2645-2014Class II
Ultraslim. These include all products labeled as UltraSlim, Luxurian, BioSlim Lipo, Cellulize, Slim 'n Trim...
Photonica USA LLC / initiated 2014-05-06 / Terminated
Advanced Photonic Systems, LLC began a recall of Ultraslim. These include all products labeled as UltraSlim, Luxurian, BioSlim Lipo, Cellulize, Slim 'n Trim, UltraRed, UltraBlue, Slim-PRO, Dazzle Light... on . FDA classified it as Class II and gives the reason as "Marketing without marketing clearance or approval". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-2645-2014
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Photonica USA LLC
- Product
- Ultraslim. 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 program combines detoxification, red light exposure, hydration, full body vibration, massage, Niacin, Milk Thistle, and the use of compression garments. Sensible diet and exercise are recommended, but not required.
- Product code
- OLI Fat Reducing Low Level Laser
- Reason for recall
- Marketing without marketing clearance or approval.
- FDA 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 regarding this recall call 800-210-5060.
- Quantity in commerce
- 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
- Product codes and lots
- Models BR-144, BRS-144 and BRC-144
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2645-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2646-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2647-2014 | Class II | Terminated | Voluntary: Firm initiated |
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