FDA.reportPublic FDA data

NIDEK INCORPORATED

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
29369212936921NIDEK INCORPORATED1Y2026-01-016601 Cascades Court Suite 130 The Colony TX US 75056

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
105821401558835P970053EC-5000 EXCIMER LASER SYSTEMLZS1998-12-17
105821028639338K991284ANTERIOR EYE-SEGMENT ANALYSIS SYSTEMMXK1999-08-06
105821647233620K990900MICROKERATOME, MODEL MK-2000HNO1999-09-24
105821362448720K980475UNIPULSE CO2 SURGICAL LASER SYSTEMGEX1998-12-16
105822056043032K973533NIDEK STEREO DISC CAMERA(3-DX)/NIDEK STEREO FUNDUS CAMERA(3-DXF)HKI1997-11-04
105822068301446K973218NIDEK HANDYHKI1997-11-04
105822007069954K900165NIDEK, INC. BIO-DC LASER DELIVERY SYSTEMGEX1990-03-22
105821596061383K893987NIDEK MODEL YC-1200LXS1989-08-18
105821646819016K861063NIDEK KM-800 AUTO KERATOMETERHLQ1986-04-04
105821355259963K221320Scanning 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
105821054094665K203130Ophthalmic Yag Laser System YC-200HQF2020-12-07
105821813875038K192045Ophthalmic Yag Laser System YC-200HQF2019-11-15
105821414236223K190198Microperimeter MP-3, Microperimeter MP-3 Type SHKI2019-04-01
105821473306629K181345Image Filing Software NAVIS-EXNFJ2018-07-19
105821421214689K173980Specular Microscope CEM-530NQE2018-03-14
105821931355380K170302YELLOW LASER PHOTOCOAGULATOR YLC-500HQF2017-06-23
105821849559713K163564SLIT LAMP SL-2000HJO2017-05-19
105822063730380K152729MICROPERIMETER MP-3HKI2016-06-06
105821549153499K152603Green Laser Photocoagulator GYC-500HQF2016-05-02
105821404222242K151706Specular Microscope CEM- 530NQE2016-03-17
105821387092958K133358NIDEK MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM MC-500 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNITHQF2014-08-12
105821389817901K133132OPTICAL BIOMETER AL-SCANHJO2014-06-11
105821922410846K132323RS-3000 ADVANCEOBO2014-02-19
105821138599390K130565SPECULAR MICROSCOPE CEM-530NQE2013-11-27
105821163938209K121622NIDEK RS-3000OBO2013-03-14
105821268906056K113451NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EXHKI2012-05-08
105822009702827K111493NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXIHQB2011-07-27
105821050845722K110228NIDEK MULTICOLOR LASER PHOTOCOAGULATORHQB2011-02-23
105821253555942K072259OPHTHALMOSCOPE F-10MYC2008-05-06
105821075104613K061768MP-1 MICROPERIMETERHKI2006-09-28
105821662694721K050336OPD-STATION SOFTWARENCF2005-08-24
105821990307908K042785MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300GEX2004-12-14
105821536728217K032085GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000GEX2003-10-03
105821378332554K031733NON-CONTACT TONOMETER, MODEL NT-4000HKX2003-12-04
105821965864996K020876ECHOSCAN, MODEL US-1800IYO2002-05-03
105821065540907K014274NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000HKI2002-04-17
105821957848885K013760DC-3300 LASER DIODE PHOTOCOAGULATORHQF2002-02-11
105821293587411K003299OPD-SCAN, MODELS ARK-10000 AND ARK-9000HLQ2001-03-09
105821002998101
105821141280926
105821243846731
105821304069036
105821515115966
105821581849699
105821768795286
105821784030362
105822022232788
105821065756553
105821188925261
105821288353706

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HQF102020-12-07
HKI102019-04-01
NQE62018-03-14
HQB42011-07-27
GEX42004-12-14
OBO32023-03-30
HJO32017-05-19
NFJ22018-07-19
IYO22002-05-03
HLQ22001-03-09
LZS21998-12-17
LXS21989-08-18
MYC12008-05-06
NCF12005-08-24
HKX12003-12-04
HNO11999-09-24
MXK11999-08-06

PMN#