Events

Rappel de Device Recall Photonica Light Modulator

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Advanced Photonic Systems, LLC.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    69117
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2647-2014
  • Date de mise en oeuvre de l'événement
    2014-05-06
  • Date de publication de l'événement
    2014-09-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-06-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129679
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Fat reducing low level laser - Product Code OLI
  • Cause
    Marketing without marketing clearance or approval.
  • 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.

Device

Device Recall Photonica Light Modulator
  • Modèle / numéro de série
    Models ULT-1, TDR-1, and TDR-2
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • 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
  • Description du dispositif
    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.
  • Manufacturer
    Advanced Photonic Systems, LLC

Manufacturer

Advanced Photonic Systems, LLC
  • Adresse du fabricant
    Advanced Photonic Systems, LLC, 1980 N Atlantic Ave, Suite 930, Cocoa Beach FL 32931-5213
  • Société-mère du fabricant (2017)
    Advanced Photonic Systems Llc
  • Source
    USFDA