2 results
·
30ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
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.
FDA Recall
Terminated
·Iridex Corporation·Product code GEX·February 27, 2018
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.
FDA Enforcement
Class II
·Terminated·Iridex Corporation·March 28, 2018