Specular Microscope CEM-530— 510(k) K173980

Clearance details

Applicant

Nidek Co., Ltd.

Product code

Code NQE

Device class

Class 2

Regulation

21 CFR 886.1850

Advisory panel

Ophthalmic

Date received

2017-12-29

Decision date

2018-03-14

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Gamagori, JP

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• Z-0771-2020 — NIDEK Specular Microscope, Model CEM-530 - Product Usage: The device provides noncontact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analyzed through the captured images.Class III·Terminated·Nidek, Inc.·20190225

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K173980.