NQE

Microscope, Specular

Product code
NQE
Device name
Microscope, Specular
Device class
Class 2
21 CFR
21 CFR 886.1850
Medical specialty
Ophthalmic
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (all years, FDA)
9 (all years; only the last 3 years are listed here)

FDA classification definition

Specular microscopes are used for the microscopic imaging and assessment of the corneal endothelial cell layer in vivo or in vitro.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: NQE
Classification and pathway per current FDA publications. Data from openFDA (CC0).