Photonica Light Modulator. These include all products labeled as UltraSlim, Luxurian, BioSlim Lipo, Cellulize, Slim 'n T

FDA device recall Z-2647-2014 · posted 2014-09-16 · Terminated

Recall details

Recalling firm

Advanced Photonic Systems, LLC

Reason for recall

Marketing without marketing clearance or approval.

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.

Root cause

No Marketing Application

Status

Terminated

Product code

OLI

Quantity affected

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

Date initiated

2014-05-06

Date posted

2014-09-16

Date terminated

2015-06-24

Location

Cocoa Beach, FL