Nidek Co., Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
20
Inspections
2
Compliance Actions
1

Recent 510(k) Clearances

K-NumberDeviceDate
K221320Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning March 30, 2023
K203130Ophthalmic Yag Laser System YC-200December 7, 2020
K192045Ophthalmic Yag Laser System YC-200November 15, 2019
K190198Microperimeter MP-3, Microperimeter MP-3 Type SApril 1, 2019
K181345Image Filing Software NAVIS-EXJuly 19, 2018
K173980Specular Microscope CEM-530March 14, 2018
K170302YELLOW LASER PHOTOCOAGULATOR YLC-500June 23, 2017
K163564SLIT LAMP SL-2000May 19, 2017
K152729MICROPERIMETER MP-3June 6, 2016
K152603Green Laser Photocoagulator GYC-500May 2, 2016
K151706Specular Microscope CEM- 530March 17, 2016
K133358NIDEK MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM MC-500 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERAugust 12, 2014
K133132OPTICAL BIOMETER AL-SCANJune 11, 2014
K132323RS-3000 ADVANCEFebruary 19, 2014
K130565SPECULAR MICROSCOPE CEM-530November 27, 2013
K131894NIDEK GREEN LASER PHOTOCOAGULTOR MODEL GYC-1000 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIOctober 31, 2013
K121622NIDEK RS-3000March 14, 2013
K111493NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXIJuly 27, 2011
K072259OPHTHALMOSCOPE F-10May 6, 2008
K003299OPD-SCAN, MODELS ARK-10000 AND ARK-9000March 9, 2001