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U.S. Department of Health and Human Services

Class 2 Device Recall Luxurian

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 Class 2 Device Recall Luxuriansee related information
Date Initiated by FirmMay 06, 2014
Date PostedSeptember 16, 2014
Recall Status1 Terminated 3 on June 24, 2015
Recall NumberZ-2646-2014
Recall Event ID 69117
Product Classification Fat reducing low level laser - Product Code OLI
ProductLuxurian. 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 Model 150
Recalling Firm/
Manufacturer		 Advanced Photonic Systems, LLC
1980 N Atlantic Ave
Suite 930
Cocoa Beach FL 32931-5213
For Additional Information ContactAdyaribeth Torres
800-210-5060
Manufacturer Reason
for Recall		Marketing without marketing clearance or approval.
FDA Determined
Cause 2		No Marketing Application
ActionAdvanced 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 Commerce235 Total
DistributionWorldwide 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 CycleTPLC 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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