Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Nidek Co., Ltd.

FDA 510(k) & PMA Approved Devices — 17 products

Total Devices17
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K221320 Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EXOBO2023-03-30 View
510(k) K203130 Ophthalmic Yag Laser System YC-200HQF2020-12-07 View
510(k) K192045 Ophthalmic Yag Laser System YC-200HQF2019-11-15 View
510(k) K190198 Microperimeter MP-3, Microperimeter MP-3 Type SHKI2019-04-01 View
510(k) K181345 Image Filing Software NAVIS-EXNFJ2018-07-19 View
510(k) K173980 Specular Microscope CEM-530NQE2018-03-14 View
510(k) K170302 YELLOW LASER PHOTOCOAGULATOR YLC-500HQF2017-06-23 View
510(k) K163564 SLIT LAMP SL-2000HJO2017-05-19 View
510(k) K152729 MICROPERIMETER MP-3HKI2016-06-06 View
510(k) K152603 Green Laser Photocoagulator GYC-500HQF2016-05-02 View
510(k) K151706 Specular Microscope CEM- 530NQE2016-03-17 View
510(k) K130565 SPECULAR MICROSCOPE CEM-530NQE2013-11-27 View
510(k) K131894 NIDEK GREEN LASER PHOTOCOAGULTOR MODEL GYC-1000 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNITGEX2013-10-31 View
510(k) K121622 NIDEK RS-3000OBO2013-03-14 View
510(k) K111493 NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXIHQB2011-07-27 View
510(k) K072259 OPHTHALMOSCOPE F-10MYC2008-05-06 View
510(k) K003299 OPD-SCAN, MODELS ARK-10000 AND ARK-9000HLQ2001-03-09 View
↑