NIDEK CO., LTD.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
8030392	3002807715	NIDEK CO., LTD.	1	N	2026-01-01	34-14 MAEHAMA, HIROISHI-CHO GAMAGORI, AICHI JP 443-0038

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
10583	1401558835	P970053	EC-5000 EXCIMER LASER SYSTEM	LZS	1998-12-17
10583	1028639338	K991284	ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM	MXK	1999-08-06
10583	1647233620	K990900	MICROKERATOME, MODEL MK-2000	HNO	1999-09-24
10583	1362448720	K980475	UNIPULSE CO2 SURGICAL LASER SYSTEM	GEX	1998-12-16
10583	2056043032	K973533	NIDEK STEREO DISC CAMERA(3-DX)/NIDEK STEREO FUNDUS CAMERA(3-DXF)	HKI	1997-11-04
10583	2068301446	K973218	NIDEK HANDY	HKI	1997-11-04
10583	1335380394	K930444	MARCO STANDARD KERATOMETERS	HJB	1993-08-09
10583	1923497356	K930441	MARCO STANDARD LENSMETERS 101,201	HLM	1993-07-06
10583	1129029559	K901686	NIDEK/PHACO EMULSIFICATION SYSTEM MODEL CV-8000	HQC	1990-06-08
10583	2007069954	K900165	NIDEK, INC. BIO-DC LASER DELIVERY SYSTEM	GEX	1990-03-22
10583	1596061383	K893987	NIDEK MODEL YC-1200	LXS	1989-08-18
10583	1646819016	K861063	NIDEK KM-800 AUTO KERATOMETER	HLQ	1986-04-04
10583	1355259963	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-EX	OBO	2023-03-30
10583	1054094665	K203130	Ophthalmic Yag Laser System YC-200	HQF	2020-12-07
10583	1813875038	K192045	Ophthalmic Yag Laser System YC-200	HQF	2019-11-15
10583	1414236223	K190198	Microperimeter MP-3, Microperimeter MP-3 Type S	HKI	2019-04-01
10583	1473306629	K181345	Image Filing Software NAVIS-EX	NFJ	2018-07-19
10583	1421214689	K173980	Specular Microscope CEM-530	NQE	2018-03-14
10583	1931355380	K170302	YELLOW LASER PHOTOCOAGULATOR YLC-500	HQF	2017-06-23
10583	1849559713	K163564	SLIT LAMP SL-2000	HJO	2017-05-19
10583	2063730380	K152729	MICROPERIMETER MP-3	HKI	2016-06-06
10583	1549153499	K152603	Green Laser Photocoagulator GYC-500	HQF	2016-05-02
10583	1404222242	K151706	Specular Microscope CEM- 530	NQE	2016-03-17
10583	1387092958	K133358	NIDEK MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM MC-500 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT	HQF	2014-08-12
10583	1389817901	K133132	OPTICAL BIOMETER AL-SCAN	HJO	2014-06-11
10583	1922410846	K132323	RS-3000 ADVANCE	OBO	2014-02-19
10583	1138599390	K130565	SPECULAR MICROSCOPE CEM-530	NQE	2013-11-27
10583	1163938209	K121622	NIDEK RS-3000	OBO	2013-03-14
10583	1268906056	K113451	NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EX	HKI	2012-05-08
10583	2009702827	K111493	NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI	HQB	2011-07-27
10583	1050845722	K110228	NIDEK MULTICOLOR LASER PHOTOCOAGULATOR	HQB	2011-02-23
10583	1253555942	K072259	OPHTHALMOSCOPE F-10	MYC	2008-05-06
10583	1075104613	K061768	MP-1 MICROPERIMETER	HKI	2006-09-28
10583	1662694721	K050336	OPD-STATION SOFTWARE	NCF	2005-08-24
10583	1990307908	K042785	MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300	GEX	2004-12-14
10583	1536728217	K032085	GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000	GEX	2003-10-03
10583	1378332554	K031733	NON-CONTACT TONOMETER, MODEL NT-4000	HKX	2003-12-04
10583	1965864996	K020876	ECHOSCAN, MODEL US-1800	IYO	2002-05-03
10583	1065540907	K014274	NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000	HKI	2002-04-17
10583	1957848885	K013760	DC-3300 LASER DIODE PHOTOCOAGULATOR	HQF	2002-02-11
10583	1293587411	K003299	OPD-SCAN, MODELS ARK-10000 AND ARK-9000	HLQ	2001-03-09
10583	1284449456
10583	1515115966
10583	1768795286
10583	1002998101
10583	1065756553
10583	1141280926
10583	1188925261
10583	1243846731
10583	1288353706
10583	1304069036
10583	1581849699
10583	1784030362
10583	2022232788

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
HKI	7	2019-04-01
HQF	6	2020-12-07
GEX	4	2004-12-14
OBO	3	2023-03-30
NQE	3	2018-03-14
HJO	2	2017-05-19
HQB	2	2011-07-27
HLQ	2	2001-03-09
NFJ	1	2018-07-19
MYC	1	2008-05-06
NCF	1	2005-08-24
HKX	1	2003-12-04
IYO	1	2002-05-03
HNO	1	1999-09-24
MXK	1	1999-08-06
LZS	1	1998-12-17
HJB	1	1993-08-09
HLM	1	1993-07-06
HQC	1	1990-06-08
LXS	1	1989-08-18

PMA#

Nidek EC-5000 Excimer Laser System
2018-01-12
NIDEK CO., LTD.
EC-5000 EXCIMER LASER SYSTEM
2017-06-08
NIDEK CO., LTD.
NIDEK EXCLAIMER LASER SYSTEM EC-5000
2015-03-30
NIDEK CO., LTD.
NIDEK EXCIMER LASER SYSTEM EC-5000
2014-11-21
NIDEK CO., LTD.
NIDEK EXCIMER LASER SYSTEM EC-5000
2014-11-14
NIDEK CO., LTD.
NIDEK 2000 EC-5000 EXCIMER LASER SYSTEM
2013-09-30
NIDEK CO., LTD.
NIDEK EC-5000 EXCIMER LASER SYSTEM
2012-12-12
NIDEK CO., LTD.
NIDEK EC-5000 EXCIMER LASER
2006-11-08
NIDEK CO., LTD.
NIDEK EC-5000 EXCIMER LASER SYSTEM
2006-10-11
NIDEK CO., LTD.
NIDEK EC-5000 EXCIMER LASER SYSTEM
2004-05-28
NIDEK CO., LTD.
NIDEK EC-5000 EXCIMER LASER SYSTEM
2002-10-28
NIDEK CO., LTD.
NIDEK EC-5000 EXCIMER LASER SYSTEM
2001-09-04
NIDEK CO., LTD.
NIDEK EC-5000 EXCIMER LASER SYSTEM
2001-03-15
NIDEK CO., LTD.
EC-5000 EXCIMER LASER SYSTEM
2000-10-25
NIDEK CO., LTD.
NIDEK EC-5000 EXCIMER LASER SYSTEM
2000-04-14
NIDEK CO., LTD.
NIDEK EC-5000 EXCIMER LASER SYSTEM (PARK)
1999-09-29
NIDEK CO., LTD.
EC-5000 EXCIMER LASER SYSTEM
1998-12-17
NIDEK CO., LTD.

PMN#

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
2023-03-30
Nidek Co., Ltd.
Ophthalmic Yag Laser System YC-200
2020-12-07
Nidek Co., Ltd.
Ophthalmic Yag Laser System YC-200
2019-11-15
Nidek Co., Ltd.
Specular Microscope CEM-530
2018-03-14
Nidek Co., Ltd.
YELLOW LASER PHOTOCOAGULATOR YLC-500
2017-06-23
NIDEK CO., LTD.
SLIT LAMP SL-2000
2017-05-19
NIDEK CO., LTD.
MICROPERIMETER MP-3
2016-06-06
NIDEK CO., LTD.
Green Laser Photocoagulator GYC-500
2016-05-02
NIDEK CO., LTD.
Specular Microscope CEM- 530
2016-03-17
NIDEK CO., LTD.
OPTICAL BIOMETER AL-SCAN
2014-06-11
NIDEK CO., LTD.
RS-3000 ADVANCE
2014-02-19
NIDEK CO., LTD.
SPECULAR MICROSCOPE CEM-530
2013-11-27
NIDEK CO., LTD.
NIDEK GREEN LASER PHOTOCOAGULTOR MODEL GYC-1000 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT
2013-10-31
NIDEK CO., LTD.
NIDEK RS-3000
2013-03-14
NIDEK CO., LTD.
NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI
2011-07-27
NIDEK CO., LTD.
OPHTHALMOSCOPE F-10
2008-05-06
NIDEK CO., LTD.
OPD-SCAN, MODELS ARK-10000 AND ARK-9000
2001-03-09
NIDEK CO., LTD.