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U.S. Department of Health and Human Services

Class 2 Device Recall Photonica Light Modulator

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  Class 2 Device Recall Photonica Light Modulator see related information
Date Initiated by Firm May 06, 2014
Date Posted September 16, 2014
Recall Status1 Terminated 3 on June 24, 2015
Recall Number Z-2647-2014
Recall Event ID 69117
Product Classification Fat reducing low level laser - Product Code OLI
Product Photonica Light Modulator. 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.
Code Information Models ULT-1, TDR-1, and TDR-2
Recalling Firm/
Manufacturer		 Advanced Photonic Systems, LLC
1980 N Atlantic Ave
Suite 930
Cocoa Beach FL 32931-5213
For Additional Information Contact Adyaribeth Torres
800-210-5060
Manufacturer Reason
for Recall		 Marketing without marketing clearance or approval.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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