Device Recall STAR S4 IR Excimer Laser System; Software Version 5.10

  • Modelo / Serial
    Model # 0030-4653
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) including Puerto Rico and countries of Africa, Asian Pacific, Canada, Europe, Japan, Latin America, and the Middle East.
  • Descripción del producto
    STAR S4 IR Excimer Laser System; Software Version 5.10 || Mfg by : AMO Manufacturing USA, LLC || 510 Cottonwood Drive || Milpitas, CA 95035 || Iris registration is designed to compensate for pupil centroid shift and cycloration, both of Which may occur because of patient characteristics and the different environments at the time of measurement and at the time of treatment.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    AMO Manufacturing USA, LLC, 510 Cottonwood Dr, Milpitas CA 95035-7403
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA