Product code NQE

Device name
Microscope, Specular
Medical specialty
Ophthalmic
Device class
2
Regulation number
886.1850
Review panel
OP
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
Y
Summary malfunction reporting
Eligible
Definition
Specular microscopes are used for the microscopic imaging and assessment of the corneal endothelial cell layer in vivo or in vitro.
Source
FDA openFDA device classification dataset