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 Nidek Co., Ltd., Konan Medical, Inc. and Topcon Corporation.

Total

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

Specular Microscope CEM-530

EM-4000 Specular Microscope

Specular Microscope CEM- 530

SP-1PSpecular Microscope

SPECULAR MICROSCOPE CEM-530

KONAN SPECULAR MICROSCOPE XIV

K120264

Konan Medical, Inc.

Ophthalmic · 72d

About Product Code NQE - Regulatory Context

Related FDA 510(k) Regulatory Insights

Data Source

FDA 510(k) public files . 175,972 total devices indexed.

Latest clearance: Mar 26, 2020

Product Code Info

Code	NQE
Device class	Class II
CFR	21 CFR 886.1850
Panel	Ophthalmic

Verify on FDA.gov

View NQE classification on FDA.gov →