Device Recall STAR S4 IR Excimer Laser System; Software Version 5.15

  • Modèle / numéro de série
    Model # 0030-4736
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including Puerto Rico and countries of Africa, Asian Pacific, Canada, Europe, Japan, Latin America, and the Middle East.
  • Description du dispositif
    STAR S4 IR Excimer Laser System; Software Version 5.15 || 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

Fabricant

  • Adresse du fabricant
    AMO Manufacturing USA, LLC, 510 Cottonwood Dr, Milpitas CA 95035-7403
  • Société-mère du fabricant (2017)
  • Source
    USFDA