Cleared Traditional

Specular Microscope CEM-530

K173980 · Nidek Co., Ltd. · Ophthalmic

Mar 2018

Decision

75d

Days

Class 2

Risk

About This 510(k) Submission

K173980 is an FDA 510(k) clearance for the Specular Microscope CEM-530, a Microscope, Specular (Class II — Special Controls, product code NQE), submitted by Nidek Co., Ltd. (Gamagori, JP). The FDA issued a Cleared decision on March 14, 2018, 75 days after receiving the submission on December 29, 2017. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1850.

Submission Details

510(k) Number	K173980 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 29, 2017
Decision Date	March 14, 2018
Days to Decision	75 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.