Device Recall STAR S4 IR Excimer Laser System; Software Version 5.16

  • 모델명 / 제조번호(시리얼번호)
    Model # 0030-4793
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) including Puerto Rico and countries of Africa, Asian Pacific, Canada, Europe, Japan, Latin America, and the Middle East.
  • 제품 설명
    STAR S4 IR Excimer Laser System; Software Version 5.16 || 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

제조사

  • 제조사 주소
    AMO Manufacturing USA, LLC, 510 Cottonwood Dr, Milpitas CA 95035-7403
  • 제조사 모회사 (2017)
  • Source
    USFDA