NQE · Class II · 21 CFR 886.1850

FDA Product Code NQE: Microscope, Specular

Specular Microscopes Are Used For The Microscopic Imaging And Assessment Of The Corneal Endothelial Cell Layer In Vivo Or In Vitro.

Leading manufacturers include Tomey Corporation, Nidek Co., Ltd. and Konan Medical, Inc..

9
Total
9
Cleared
229d
Avg days
2004
Since

FDA 510(k) Cleared Microscope, Specular Devices (Product Code NQE)

9 devices
1–9 of 9
Cleared Mar 26, 2020
Konan Specular Microscope XVII
K191558
Konan Medical, Inc.
Ophthalmic · 288d
Cleared Mar 14, 2018
Specular Microscope CEM-530
K173980
Nidek Co., Ltd.
Ophthalmic · 75d
Cleared Jan 19, 2018
EM-4000 Specular Microscope
K171313
Tomey Corporation
Ophthalmic · 260d

About Product Code NQE - Regulatory Context