510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NQEClass II

Microscope, Specular

21 CFR 886.1850 / Ophthalmic
FDA source (opens on fda.gov)

NQE is the FDA product code for Microscope, Specular, a class II device type, regulated under 21 CFR 886.1850. FDA's definition for this code reads: "Specular microscopes are used for the microscopic imaging and assessment of the corneal endothelial cell layer in vivo or in vitro". As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
NQE
Device name
Microscope, Specular
FDA definition
Specular microscopes are used for the microscopic imaging and assessment of the corneal endothelial cell layer in vivo or in vitro.
Regulation
21 CFR 886.1850
Device class
Class II
Review panel
Ophthalmic
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
9
Ingested recalls
2

Clearances, product code NQE

By decision year
9 clearances under product code NQE with a decision year between 2004 and 2020, 2018 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code NQE by decision year
YearClearances
20041
20081
20121
20131
20151
20161
20182
20201

Applicants with the most clearances

Product code NQE
Applicants holding the most 510(k) clearances under product code NQE
ApplicantClearances
Konan Medical, Inc.4
Nidek Co., Ltd.2
Nidek Co., Ltd.1
Tomey Corporation1
Topcon Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code