Device Recall Laser Indirect Ophthalmoscope (LIO) .

  • Model / Serial
    Device Identity : 87300, 87301, 87302, 87303, 87304
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA Distribution and to the countries of : China, Germany, Australia, Canada, Ireland, Lebanon, Japan, Israel and Qatar
  • Product Description
    Iridex TruFocus LIO Premiere" Laser Indirect Ophthalmoscope ( LIO ) || The LIO is a headmounted indirect ophthalmoscope which is used with a handheld lens to view and perform laser treatments on a patient s retina. It allows binocular visualization of the peripheral retina and can be used to evaluate and treat patients.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Iridex Corporation, 1212 Terra Bella Ave, Mountain View CA 94043-1824
  • Manufacturer Parent Company (2017)
  • Source
    USFDA