Device Recall AMS GreenLight PV Surgical Laser System

  • Modelo / Serial
    All units of the model.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution including US
  • Descripción del producto
    AMS brand GreenLight PV Laser System, Model-P/N: 0010-9230; || Product is manufactured and distributed by AMS Solutions, || San Jose, CA || The GreenLight Surgical Laser System and accessories are intended for use in endoscopic (cystscopic) KTP 532 nm laser resection of the prostate for the treatment of benign prostatic hyperplasia (BPH). The entire laser unit and controls are contained in a single console that is connected to external electricity and water sources. Fibers are sterile, single-use, disposable fiber optic delivery systems, designed to deliver 532nm laser energy, the fiber is connected to the laser console and used to cut, coagulate and vaporize prostate tissue.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    AMS Innovative Center - San Jose, 3070 Orchard Dr, San Jose CA 95134-2011
  • Source
    USFDA