Nidek Co., Ltd

FDA Filings

This page includes the latest FDA filings for Nidek Co., Ltd. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate
Nidek Co., Ltd.
Ophthalmic Yag Laser System YC-2002019-11-15
Nidek Co., Ltd
Microperimeter MP-3, Microperimeter MP-3 Type S2019-04-01
Nidek Co., Ltd
Image Filing Software NAVIS-EX2018-07-19
Nidek Co., Ltd.
Specular Microscope CEM-5302018-03-14

Latest Premarket Applications

PMAManufacturerDevice NameDate
NIDEK CO., LTD.
Nidek EC-5000 Excimer Laser System2018-01-12
NIDEK CO., LTD.
EC-5000 EXCIMER LASER SYSTEM2017-06-08
NIDEK CO., LTD.
NIDEK EXCLAIMER LASER SYSTEM EC-50002015-03-30
NIDEK CO., LTD.
NIDEK EXCIMER LASER SYSTEM EC-50002014-11-21
NIDEK CO., LTD.
NIDEK EXCIMER LASER SYSTEM EC-50002014-11-14
NIDEK CO., LTD.
NIDEK 2000 EC-5000 EXCIMER LASER SYSTEM2013-09-30
NIDEK CO., LTD.
NIDEK EC-5000 EXCIMER LASER SYSTEM2012-12-12
NIDEK CO., LTD.
NIDEK EC-5000 EXCIMER LASER2006-11-08
NIDEK CO., LTD.
NIDEK EC-5000 EXCIMER LASER SYSTEM2006-10-11
NIDEK CO., LTD.
NIDEK EC-5000 EXCIMER LASER SYSTEM2004-05-28
NIDEK CO., LTD.
NIDEK EC-5000 EXCIMER LASER SYSTEM2002-10-28
NIDEK CO., LTD.
NIDEK EC-5000 EXCIMER LASER SYSTEM2001-09-04
NIDEK CO., LTD.
NIDEK EC-5000 EXCIMER LASER SYSTEM2001-03-15
NIDEK CO., LTD.
EC-5000 EXCIMER LASER SYSTEM2000-10-25
NIDEK CO., LTD.
NIDEK EC-5000 EXCIMER LASER SYSTEM2000-04-14
NIDEK CO., LTD.
NIDEK EC-5000 EXCIMER LASER SYSTEM (PARK)1999-09-29
NIDEK CO., LTD.
EC-5000 EXCIMER LASER SYSTEM1998-12-17
NIDEK, INC.
ND:YAG POSTERIOR CAPSULOTOMY MODEL 1001990-03-13
NIDEK, INC.
ND:YAG POSTERIOR CAPSULOTOMY MODEL 1001989-09-08
NIDEK, INC.
ND:YAG POSTERIOR CAPSULOTOMY MODEL 1001989-08-30
NIDEK, INC.
ND:YAG POSTERIOR CAPSULOTOMY MODEL 1001988-07-28
NIDEK, INC.
ND:YAG POSTERIOR CAPSULOTOMY MODEL 1001987-06-11
NIDEK, INC.
ND:YAG POSTERIOR CAPSULOTOMY MODEL 1001987-04-08
NIDEK, INC.
ND:YAG POSTERIOR CAPSULOTOMY MODEL 1001986-12-01
NIDEK, INC.
ND:YAG POSTERIOR CAPSULOTOMY MODEL 1001985-11-26
NIDEK, INC.
ND:YAG POSTERIOR CAPSULOTOMY MODEL 1001985-05-02
NIDEK, INC.
ND:YAG POSTERIOR CAPSULOTOMY MODEL 1001985-02-14
NIDEK, INC.
ND:YAG POSTERIOR CAPSULOTOMY MODEL 1001984-10-23
NIDEK, INC.
ND:YAG POSTERIOR CAPSULOTOMY MODEL 1001984-09-27

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
Endophotocoagulation Delivery Unit
NIDEK CO.,LTD.2019-09-16
Endophotocoagulation Delivery Unit
NIDEK CO.,LTD.2019-09-16
Tabletop Refraction System
NIDEK CO.,LTD.2019-07-22
Space Saving Chart
NIDEK CO.,LTD.2019-07-22
SYSTEM CHART
NIDEK CO.,LTD.2019-07-22
REFRACTOR
NIDEK CO.,LTD.2019-07-22
SPACE SAVING CHART
NIDEK CO.,LTD.2019-07-22
System Table
NIDEK CO.,LTD.2019-04-03
System Table
NIDEK CO.,LTD.2019-04-03
AUTO REF/KERATOMETER
NIDEK CO.,LTD.2019-03-11
AUTO REFRACTOMETER
NIDEK CO.,LTD.2019-03-11
Data Acquisition Service for NAVIS-EX
NIDEK CO.,LTD.2018-09-24
AL-Scan Viewer for NAVIS-EX
NIDEK CO.,LTD.2018-09-24
CEM Viewer for NAVIS-EX
NIDEK CO.,LTD.2018-09-24
NON-MYDRIATIC AUTO FUNDUS CAMERA
NIDEK CO.,LTD.2018-09-24
Image filing software
NIDEK CO.,LTD.2018-09-24
Sterilized Endophoto Probe(25G/Coaxial)
NIDEK CO.,LTD.2018-05-24
Sterilized Endophoto Probe(23G/Coaxial)
NIDEK CO.,LTD.2018-05-24
Sterilized Endophoto Probe(20G/Coaxial)
NIDEK CO.,LTD.2018-05-24
Sterilized Endophoto Probe(27G/Straight)
NIDEK CO.,LTD.2018-05-24
Sterilized Endophoto Probe(25G/Angled)
NIDEK CO.,LTD.2018-05-24
Sterilized Endophoto Probe(25G/Straight)
NIDEK CO.,LTD.2018-05-24
Sterilized Endophoto Probe(23G/Angled)
NIDEK CO.,LTD.2018-05-24
Sterilized Endophoto Probe(23G/Straight)
NIDEK CO.,LTD.2018-05-24
Sterilized Endophoto Probe(20G/Angled)
NIDEK CO.,LTD.2018-05-24
Sterilized Endophoto Probe(20G/Straight)
NIDEK CO.,LTD.2018-05-24
AUTO LENSMETER
NIDEK CO.,LTD.2018-05-21
AUTO LENSMETER
NIDEK CO.,LTD.2018-05-21
Scan Attachable delivery unit (900BQ)
NIDEK CO.,LTD.2018-05-21
Scan slit lamp delivery unit (NIDEK SL)
NIDEK CO.,LTD.2018-05-21
Scan Attachable delivery unit (SL130)
NIDEK CO.,LTD.2018-05-21
Bio delivery unit (OMEGA 500)
NIDEK CO.,LTD.2018-05-21
Slit lamp delivery unit (NIDEK SL)
NIDEK CO.,LTD.2018-05-21
Attachable delivery unit (SL130)
NIDEK CO.,LTD.2018-05-21
Yellow Laser Photocoagulator
NIDEK CO.,LTD.2018-05-21

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