Cleared Traditional

SPECULAR MICROSCOPE CEM-530

K130565 · Nidek Co., Ltd. · Ophthalmic

Nov 2013

Decision

268d

Days

Class 2

Risk

About This 510(k) Submission

K130565 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. (Andover, US). The FDA issued a Cleared decision on November 27, 2013, 268 days after receiving the submission on March 4, 2013. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1850.

Submission Details

510(k) Number	K130565 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 04, 2013
Decision Date	November 27, 2013
Days to Decision	268 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.