Cleared Traditional

EM-4000 Specular Microscope

K171313 · Tomey Corporation · Ophthalmic

Jan 2018

Decision

260d

Days

Class 2

Risk

About This 510(k) Submission

K171313 is an FDA 510(k) clearance for the EM-4000 Specular Microscope, a Microscope, Specular (Class II — Special Controls, product code NQE), submitted by Tomey Corporation (Nagoya, JP). The FDA issued a Cleared decision on January 19, 2018, 260 days after receiving the submission on May 4, 2017. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1850.

Submission Details

510(k) Number	K171313 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 04, 2017
Decision Date	January 19, 2018
Days to Decision	260 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF

Device Classification

Product Code	NQE — Microscope, Specular
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 886.1850
Definition	Specular Microscopes Are Used For The Microscopic Imaging And Assessment Of The Corneal Endothelial Cell Layer In Vivo Or In Vitro.