Cleared Traditional

Specular Microscope CEM- 530

K151706 · Nidek Co., Ltd. · Ophthalmic

Mar 2016

Decision

267d

Days

Class 2

Risk

About This 510(k) Submission

K151706 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 17, 2016, 267 days after receiving the submission on June 24, 2015. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1850.

Submission Details

510(k) Number	K151706 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 24, 2015
Decision Date	March 17, 2016
Days to Decision	267 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.