FDA.reportPublic FDA data

NIDEK MEDICAL PRODUCTS, INC.

Matched from indexed company URL: NIDEK INCORPORATED

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10392151039215NIDEK MEDICAL PRODUCTS, INC.1N2026-01-013949 VALLEY EAST INDUSTRIAL DR Birmingham AL US 35217
29369212936921NIDEK INCORPORATED1Y2026-01-016601 Cascades Court Suite 130 The Colony TX US 75056
80303923002807715NIDEK CO., LTD.1N2026-01-0134-14 MAEHAMA, HIROISHI-CHO GAMAGORI, AICHI JP 443-0038
30028077153002807715NIDEK CO., LTD. HAMACHO PLANT1N2026-01-0167-4 HAMA-CHO GAMAGORI, AICHI JP 4430036

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
04987669101056DIGITAL MEDICAL SCOPE - DS-10EA Adapter is designed to connect the control unit of DS-10 and the existing endoscope in the market. The assembly system (control unit & DS-10EA Adapter & existing endoscope in the market) can be used to record digital photographs and video of the body.1-800-223-9044info@nidek.com
04987669101070DIGITAL MEDICAL SCOPE - The assembly system (control unit & DS-10EA Adapter & existing endoscope in the market) can be used to record digital photographs and video ofthe body.1-800-223-9044info@nidek.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
105821401558835P970053EC-5000 EXCIMER LASER SYSTEMLZS1998-12-17
105831401558835P970053EC-5000 EXCIMER LASER SYSTEMLZS1998-12-17
105841401558835P970053EC-5000 EXCIMER LASER SYSTEMLZS1998-12-17
105821028639338K991284ANTERIOR EYE-SEGMENT ANALYSIS SYSTEMMXK1999-08-06
105831028639338K991284ANTERIOR EYE-SEGMENT ANALYSIS SYSTEMMXK1999-08-06
105841028639338K991284ANTERIOR EYE-SEGMENT ANALYSIS SYSTEMMXK1999-08-06
105821647233620K990900MICROKERATOME, MODEL MK-2000HNO1999-09-24
105831647233620K990900MICROKERATOME, MODEL MK-2000HNO1999-09-24
105841647233620K990900MICROKERATOME, MODEL MK-2000HNO1999-09-24
105821362448720K980475UNIPULSE CO2 SURGICAL LASER SYSTEMGEX1998-12-16
105831362448720K980475UNIPULSE CO2 SURGICAL LASER SYSTEMGEX1998-12-16
105841362448720K980475UNIPULSE CO2 SURGICAL LASER SYSTEMGEX1998-12-16
105822056043032K973533NIDEK STEREO DISC CAMERA(3-DX)/NIDEK STEREO FUNDUS CAMERA(3-DXF)HKI1997-11-04
105832056043032K973533NIDEK STEREO DISC CAMERA(3-DX)/NIDEK STEREO FUNDUS CAMERA(3-DXF)HKI1997-11-04
105842056043032K973533NIDEK STEREO DISC CAMERA(3-DX)/NIDEK STEREO FUNDUS CAMERA(3-DXF)HKI1997-11-04
105822068301446K973218NIDEK HANDYHKI1997-11-04
105832068301446K973218NIDEK HANDYHKI1997-11-04
105842068301446K973218NIDEK HANDYHKI1997-11-04
105831335380394K930444MARCO STANDARD KERATOMETERSHJB1993-08-09
105841335380394K930444MARCO STANDARD KERATOMETERSHJB1993-08-09
105831923497356K930441MARCO STANDARD LENSMETERS 101,201HLM1993-07-06
105841923497356K930441MARCO STANDARD LENSMETERS 101,201HLM1993-07-06
105831129029559K901686NIDEK/PHACO EMULSIFICATION SYSTEM MODEL CV-8000HQC1990-06-08
105841129029559K901686NIDEK/PHACO EMULSIFICATION SYSTEM MODEL CV-8000HQC1990-06-08
105822007069954K900165NIDEK, INC. BIO-DC LASER DELIVERY SYSTEMGEX1990-03-22
105832007069954K900165NIDEK, INC. BIO-DC LASER DELIVERY SYSTEMGEX1990-03-22
105842007069954K900165NIDEK, INC. BIO-DC LASER DELIVERY SYSTEMGEX1990-03-22
105821596061383K893987NIDEK MODEL YC-1200LXS1989-08-18
105831596061383K893987NIDEK MODEL YC-1200LXS1989-08-18
105841596061383K893987NIDEK MODEL YC-1200LXS1989-08-18
105821646819016K861063NIDEK KM-800 AUTO KERATOMETERHLQ1986-04-04
105831646819016K861063NIDEK KM-800 AUTO KERATOMETERHLQ1986-04-04
105841646819016K861063NIDEK 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
105831355259963K221320Scanning 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
105841355259963K221320Scanning 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
105831054094665K203130Ophthalmic Yag Laser System YC-200HQF2020-12-07
105841054094665K203130Ophthalmic Yag Laser System YC-200HQF2020-12-07
731461894422180K192693Nuvo Nano Portable Oxygen ConcentratorCAW2020-05-07
105821813875038K192045Ophthalmic Yag Laser System YC-200HQF2019-11-15
105831813875038K192045Ophthalmic Yag Laser System YC-200HQF2019-11-15
105841813875038K192045Ophthalmic Yag Laser System YC-200HQF2019-11-15
105821414236223K190198Microperimeter MP-3, Microperimeter MP-3 Type SHKI2019-04-01
105831414236223K190198Microperimeter MP-3, Microperimeter MP-3 Type SHKI2019-04-01
105841414236223K190198Microperimeter MP-3, Microperimeter MP-3 Type SHKI2019-04-01
105821473306629K181345Image Filing Software NAVIS-EXNFJ2018-07-19
105831473306629K181345Image Filing Software NAVIS-EXNFJ2018-07-19
105841473306629K181345Image Filing Software NAVIS-EXNFJ2018-07-19
105821421214689K173980Specular Microscope CEM-530NQE2018-03-14
105831421214689K173980Specular Microscope CEM-530NQE2018-03-14
105841421214689K173980Specular Microscope CEM-530NQE2018-03-14
105821931355380K170302YELLOW LASER PHOTOCOAGULATOR YLC-500HQF2017-06-23
105831931355380K170302YELLOW LASER PHOTOCOAGULATOR YLC-500HQF2017-06-23
105841931355380K170302YELLOW LASER PHOTOCOAGULATOR YLC-500HQF2017-06-23
105821849559713K163564SLIT LAMP SL-2000HJO2017-05-19
105831849559713K163564SLIT LAMP SL-2000HJO2017-05-19
105841849559713K163564SLIT LAMP SL-2000HJO2017-05-19
105822063730380K152729MICROPERIMETER MP-3HKI2016-06-06
105832063730380K152729MICROPERIMETER MP-3HKI2016-06-06
105842063730380K152729MICROPERIMETER MP-3HKI2016-06-06
105821549153499K152603Green Laser Photocoagulator GYC-500HQF2016-05-02
105831549153499K152603Green Laser Photocoagulator GYC-500HQF2016-05-02
105841549153499K152603Green Laser Photocoagulator GYC-500HQF2016-05-02
105821404222242K151706Specular Microscope CEM- 530NQE2016-03-17
105831404222242K151706Specular Microscope CEM- 530NQE2016-03-17
105841404222242K151706Specular Microscope CEM- 530NQE2016-03-17
105821387092958K133358NIDEK MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM MC-500 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNITHQF2014-08-12
105831387092958K133358NIDEK MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM MC-500 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNITHQF2014-08-12
105841387092958K133358NIDEK MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM MC-500 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNITHQF2014-08-12
105821389817901K133132OPTICAL BIOMETER AL-SCANHJO2014-06-11
105831389817901K133132OPTICAL BIOMETER AL-SCANHJO2014-06-11
105841389817901K133132OPTICAL BIOMETER AL-SCANHJO2014-06-11
105821922410846K132323RS-3000 ADVANCEOBO2014-02-19
105831922410846K132323RS-3000 ADVANCEOBO2014-02-19
105841922410846K132323RS-3000 ADVANCEOBO2014-02-19
105821138599390K130565SPECULAR MICROSCOPE CEM-530NQE2013-11-27
105831138599390K130565SPECULAR MICROSCOPE CEM-530NQE2013-11-27
105841138599390K130565SPECULAR MICROSCOPE CEM-530NQE2013-11-27
731461913222471K123738MARK 5 NUVO LITE OCSI, MARK 5 NUVO LITE STDCAW2013-02-28
105821163938209K121622NIDEK RS-3000OBO2013-03-14
105831163938209K121622NIDEK RS-3000OBO2013-03-14
105841163938209K121622NIDEK RS-3000OBO2013-03-14
105841855852347K120982DIGITAL EYE-FUNDUS CAMERAHKI2012-09-28
105821268906056K113451NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EXHKI2012-05-08
105831268906056K113451NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EXHKI2012-05-08
105841268906056K113451NON-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
105832009702827K111493NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXIHQB2011-07-27
105842009702827K111493NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXIHQB2011-07-27
105821050845722K110228NIDEK MULTICOLOR LASER PHOTOCOAGULATORHQB2011-02-23
105831050845722K110228NIDEK MULTICOLOR LASER PHOTOCOAGULATORHQB2011-02-23
105841050845722K110228NIDEK MULTICOLOR LASER PHOTOCOAGULATORHQB2011-02-23
731462036666831K093308MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 STDCAW2010-01-14
105821253555942K072259OPHTHALMOSCOPE F-10MYC2008-05-06
105831253555942K072259OPHTHALMOSCOPE F-10MYC2008-05-06
105841253555942K072259OPHTHALMOSCOPE F-10MYC2008-05-06
105821075104613K061768MP-1 MICROPERIMETERHKI2006-09-28
105831075104613K061768MP-1 MICROPERIMETERHKI2006-09-28
105841075104613K061768MP-1 MICROPERIMETERHKI2006-09-28
105821662694721K050336OPD-STATION SOFTWARENCF2005-08-24
105831662694721K050336OPD-STATION SOFTWARENCF2005-08-24
105841662694721K050336OPD-STATION SOFTWARENCF2005-08-24
105821990307908K042785MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300GEX2004-12-14

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HKI252019-04-01
HQF222020-12-07
NQE122018-03-14
GEX122004-12-14
OBO92023-03-30
HQB82011-07-27
HJO72017-05-19
HLQ62001-03-09
NFJ42018-07-19
IYO42002-05-03
LZS41998-12-17
LXS41989-08-18
CAW32020-05-07
MYC32008-05-06
NCF32005-08-24
HKX32003-12-04
HNO31999-09-24
MXK31999-08-06
HJB21993-08-09
HLM21993-07-06
HQC21990-06-08
BTI12002-05-03

PMA#

PMN#

ORION

2007-04-24

NIDEK TECHNOLOGIES SRL

113 records. Showing 1-40. Next

GUDID#

OPTICAL COHERENCE TOMOGRAPHY - The NIDEK Optical Coherence Tomography RS-3000 Advance is an ophthalmic camera that allows non-invasive and non-contact observation of the shape of the fundus or retina. Fundus surface images (hereafter referred to as SLO image) are captured with the confocal laser scanning using a near-infrared light source with a wavelength of 785 nm. Cross-sectional images of the retina (hereafter referred to as OCT image) are captured with the optical interferometer using an infrared light source with a wavelength of 880 nm. With the images captured using the RS-3000 Advance, the shape and structure of the fundus or retina can be observed, and diseases can be observed. This system is comprised of the main body for capturing images, a computer (hereafter called PC) for storing and analyzing captured images, PC monitor, and an isolation transformer.In addition, the image filing software NAVIS-EX (hereafter referred to as NAVIS-EX) offers the following features:• Image analysis functions such as 3D/map color display or retinal thickness analysis• Networking for data review or analysis on PCs in separate locations

NIDEK CO.,LTD.

2016-06-24

Combination attachable delivery unit (YC-1800) - This combination delivery unit is need to comprise the combination system which enables you to emit the green laser beam or YAG laser beam while performing the observation with the slit lamp of the YAG laser system. This delivery unit is mounted on the slit lamp of the YAG laser system and connected to the NIDEK GREEN LASER PHOTOCOAGULATOR GYC-1000 using the connecting cable and fiber optic cable. The combination system allows selection between photocoagulation with the green laser beam (wavelength: 532 nm (continuous wave)) and photodisruption with the Nd:YAG laser beam (wavelength: 1064 nm (pulse laser)). In addition, they are selected easily by changing the optical path of the laserbeam with the laser select lever, and various kinds of safety devices are integrated into the system so that only the selected laser beam is emitted.The GYC2SZ-3A is the only combination delivery unit that can be connected both to the NIDEK GREEN LASER PHOTOCOAGULATOR GYC-1000 and the NIDEK OPHTHALMIC YAG LASER SYSTEM YC-1800.

NIDEK CO.,LTD.

2017-02-03

Endophotocoagulation delivery unit - This Endophotocoagulation Delivery Unit is used for endophotocoagulation. The delivery unit is comprised of an endophoto probe, a relay adapter, a protective filter unit, and a carrying case. The photocoagulation laser system can be easily formed by connecting the endophoto probe to theGREEN LASER PHOTOCOAGULATOR Model GYC-1000 main body and connecting the protective filter to the GYC-1000 main body and the surgical microscope. This photocoagulation laser system enables endophotocoagulation with the green laser (wavelength: 532 nm) while observing theaffected area through the surgical microscope. This delivery unit is intended to be used with the protective filter unit attached to surgical microscopes. NIDEK provides following four types of delivery units according to the types of protective filters and the surgical microscopes*1.Before use, check the type of your surgical microscope and delivery unit.

NIDEK CO.,LTD.

2017-02-03

Attachable delivery unit (900BQ) - This delivery unit is mounted on your HAAG type slit lamp and connected to the NIDEK GREEN LASER PHOTOCOAGULATOR, Model GYC-1000 (main body) to comprise the photocoagulation system. Moving the delivery unit aside allows the operator to select between photocoagulation with the green laser beam (wavelength: 532 nm) and observation with the slit lamp without removing the delivery unit.This unit is attachable to the following five slit lamps.• HAAG STREIT ................. Model 900BM, 900CN and 900BQ• NIDEK ............................... Model SL-250 and SL-450This model includes manipulator.

NIDEK CO.,LTD.

2017-02-01

Attachable delivery unit (SL-1800) - This delivery unit is connected to the NIDEK GREEN LASER PHOTOCOAGULATOR, Model GYC-1000 (main body) to comprise the photocoagulation system and to treat affected areas using the slit lamp, NIDEK SL-1800. The integrated delivery unit which incorporates the SL-1800 comprises the photocoagulation system in connection with the GYC-1000 main body. The attachable delivery unit is mainly the photocoagulation unit and the protective filter unit. They are attached to your slit lamp (NIDEK SL-1800) to comprise the integrated delivery unit. The comprisedintegrated delivery is connected to the GYC-1000 to comprise the photocoagulation system. This photocoagulation system allows the operator to select between photocoagulation with the green laser beam (wavelength: 532 nm) and observation of the affected area with the slit lamp.

NIDEK CO.,LTD.

2017-02-01

Attachable delivery unit (30SL) - This attachable slit lamp delivery unit allows you to form a photocoagulation system easily by mounting the delivery unit on your CARL ZEISS 30SL/M or NIDEK SL-1600 and connecting the delivery unit to the NIDEK GREEN LASER PHOTOCOAGULATOR, Model GYC-1000 main body. This unit is chiefly comprised of three units: Photocoagulation unit, protective filter unit (motorized) and illumination tower unit. With each unit attached, this laser system allows the operator to select between photocoagulation with the green laser beam (wavelength: 532 nm) and observation with the slit lamp.

NIDEK CO.,LTD.

2017-02-01

GREEN LASER PHOTOCOAGULATOR SYSTEM - The GREEN LASER PHOTOCOAGULATOR SYSTEM GYC-1000 is an ophthalmological photocoagulation system using a solid state laser (green laser beam) with a wavelength of 532nm. Like conventional laser photocoagulation systems, this system is used in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.Since the GYC-1000 uses a diode laser as its pumping light source, the efficient oscillation of the 532nm laser beam can be obtained. As the GYC-1000 can be used with various kinds of delivery units, the system can be applied to transpupillary photocoagulation using the slit lamp or indirect ophthalmoscope, and to intraocular photocoagulation using the endophotocoagulation probe.

NIDEK CO.,LTD.

2016-06-24

SPECULAR MICROSCOPE - The NIDEK Specular Microscope CEM-530 provides non-contact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analyzed through the captured images. The captured images and analysis results of endothelium are used for intraocular or corneal surgery, postoperative follow-up, and corneal observation such as for endothelial disorders or the corneal state of patients who wear extended-wear contact lenses. Observation is possible in the central area (visual angle: 5°) and peripheral area (visual angle: 27°) using a periphery capture function as well as in the center of the cornea. The captured images and analysis results can be printed on the built-in printer or optional video printer, or output to an external device over LAN connection.

NIDEK CO.,LTD.

2016-08-26

Fully Assisted Refraction System - In the conventional refraction, the patient answers the operator’s questions. According to their answers, the operator performs subjective refraction such as refining refractive errors (sphere, cylinder, prism, and such) and proceeding to the next test. In this system, the patient responds to refraction questions by themselves using the Joystick Controller in response to the voice guide from the computer.The system application enables subjective refraction according to patient operation to determine the full correction.

NIDEK CO.,LTD.

2026-03-27

CEM Viewer for NAVIS-EX - The CEM Viewer for NAVIS-EX software (hereafter referred to as CEM Viewer) is used to view the examination data of the SPECULAR MICROSCOPE CEM-530 or use the data for follow-up within IMAGE FILING SOFTWARE NAVIS-EX. This function is added to the computer as a plug-in for NAVIS-EX. The examination data is displayed, analyzed, and used for follow-up. CEM Viewer can be used to display examination data on the Viewer screen or follow up data on the Follow-Up screen. The examination data is saved and managed within NAVIS-EX. The CEM Viewer data is imported to NAVIS-EX using separate software, Data Acquisition Service for NAVIS-EX.

NIDEK CO.,LTD.

2023-06-12

80 records. Showing 1-40. Next