Microscope, Specular
Ophthalmic · 21 CFR 886.1850
Specular microscopes are used for the microscopic imaging and assessment of the corneal endothelial cell layer in vivo or in vitro.
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
2 recall events for this product code
- Nidek IncTerminatedSep 1, 2016
SPECULAR MICROSCOPE CEM-530; Software version 1.08 and 1.09.
Software version 1.08 and 1.09 for the Specular Microscope CEM 530 included a change of analysis results feature that was not reviewed and approved by the FDA.
Z-2711-2016 · View FDA record ↗ - Nidek, Inc.TerminatedUnknown
NIDEK Specular Microscope, Model CEM-530 - Product Usage: The device provides noncontact, high magnification image capture of endothelium enabling observation o
The electromagnetic noise exceeded the upper limit of the Electromagnetic Compatibility Standard (EMC: IEC 60601-1-2)
Z-0771-2020 · View FDA record ↗
Registered firms
23 firms currently registered for this product code
Nidek Incorporated
The Colony, TX, US
Nidek Co., Ltd.
GAMAGORI, AICHI, JP
Konan Medical, Inc.
NISHINOMIYA Hyogo, JP
Topcon Corp.
TOKYO, JP
Nidek Co., Ltd. Hamacho Plant
GAMAGORI, AICHI, JP
Quipment
Nancy Meurthe-et-Moselle, FR
Topcon Healthcare, Inc.
Oakland, NJ, US
Topcon Yamagata Co., Ltd
Yamagata-KEN, JP
Toyo Medical Co.
Doral, FL, US
Tomey Corporation
NAGOYA Aichi, JP
510(k) clearances
9 clearances for this product code
- Konan Medical, Inc.Mar 26, 2020
K191558 · Konan Specular Microscope XVII
- Nidek Co., Ltd.Mar 14, 2018
K173980 · Specular Microscope CEM-530
- Tomey CorporationJan 19, 2018
K171313 · EM-4000 Specular Microscope
- Nidek Co., Ltd.Mar 17, 2016
K151706 · Specular Microscope CEM- 530
- Topcon CorporationMay 29, 2015
K142417 · SP-1PSpecular Microscope
- Nidek Co., Ltd.Nov 27, 2013
K130565 · SPECULAR MICROSCOPE CEM-530
- Konan Medical, Inc.Apr 11, 2012
K120264 · KONAN SPECULAR MICROSCOPE XIV
- Konan Medical, Inc.Feb 22, 2008
K062763 · NONCON ROBO PACHY F&A