FDA 510(k) Applications Submitted by Nidek Co., Ltd.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K130565 |
03/04/2013 |
SPECULAR MICROSCOPE CEM-530 |
NIDEK CO., LTD. |
| K003299 |
10/20/2000 |
OPD-SCAN, MODELS ARK-10000 AND ARK-9000 |
NIDEK CO., LTD. |
| K133132 |
09/30/2013 |
OPTICAL BIOMETER AL-SCAN |
NIDEK CO., LTD. |
| K121622 |
06/01/2012 |
NIDEK RS-3000 |
NIDEK CO., LTD. |
| K132323 |
07/25/2013 |
RS-3000 ADVANCE |
NIDEK CO., LTD. |
| K111493 |
05/31/2011 |
NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI |
NIDEK CO., LTD. |
| K072259 |
08/14/2007 |
OPHTHALMOSCOPE F-10 |
NIDEK CO., LTD. |
| K221320 |
05/06/2022 |
Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX |
Nidek Co., LTD. |
| K192045 |
07/31/2019 |
Ophthalmic Yag Laser System YC-200 |
Nidek Co., Ltd. |
| K203130 |
10/19/2020 |
Ophthalmic Yag Laser System YC-200 |
Nidek Co., Ltd. |
| K170302 |
01/31/2017 |
YELLOW LASER PHOTOCOAGULATOR YLC-500 |
NIDEK CO., LTD. |
| K151706 |
06/24/2015 |
Specular Microscope CEM- 530 |
NIDEK CO., LTD. |
| K131894 |
06/25/2013 |
NIDEK GREEN LASER PHOTOCOAGULTOR MODEL GYC-1000 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT |
NIDEK CO., LTD. |
| K152603 |
09/11/2015 |
Green Laser Photocoagulator GYC-500 |
NIDEK CO., LTD. |
| K152729 |
09/22/2015 |
MICROPERIMETER MP-3 |
NIDEK CO., LTD. |
| K163564 |
12/19/2016 |
SLIT LAMP SL-2000 |
NIDEK CO., LTD. |
| K173980 |
12/29/2017 |
Specular Microscope CEM-530 |
Nidek Co., Ltd. |
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