Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
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
FDA enforcement reports joined to recall event Z-2645-2014
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2645-2014Class IITerminatedVoluntary: Firm initiated
Z-2646-2014Class IITerminatedVoluntary: Firm initiated
Z-2647-2014Class IITerminatedVoluntary: Firm initiated