NIDEK CO., LTD.

FDA Registration(s)#

GUDID Contact Samples#

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

• nidek.com

Registered Device Listings#

Product Codes Associated With Registrations#

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.

• Microperimeter MP-3, Microperimeter MP-3 Type S

  2019-04-01

  Nidek Co., Ltd

• Image Filing Software NAVIS-EX

  2018-07-19

  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.

• NIDEK MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM MC-500 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT

  2014-08-12

  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.

GUDID#

• AUTO LENSMETER - Lens measuring instruments / LensometersThis device is designed to measure vertex powers and prismatic effects of spectacle and contact lenses, to orientate and mark uncut lenses, and to verify the correct mounting of lenses in spectacle frames.

  NIDEK CO.,LTD.

  2026-04-20

• AUTO LENSMETER - Lens measuring instruments / LensometersThis device is designed to measure vertex powers and prismatic effects of spectacle and contact lenses, to orientate and mark uncut lenses, and to verify the correct mounting of lenses in spectacle frames.

  NIDEK CO.,LTD.

  2026-04-20

• AUTO LENSMETER - Lens measuring instruments / LensometersThis device is designed to measure vertex powers and prismatic effects of spectacle and contact lenses, to orientate and mark uncut lenses, and to verify the correct mounting of lenses in spectacle frames.

  NIDEK CO.,LTD.

  2026-04-20

• Scanning Laser Ophthalmoscope - The Nidek Mirante Scanning Laser Ophthalmoscope is an ophthalmic imaging device that allows non invasive and non-contact observation of the shape and the disease state of the fundus, anterior segment, and retina using a scanning laser ophthalmoscope (hereafter referred to as “SLO”) and/or optical coherence tomography (hereafter referred to as “OCT”).

  NIDEK CO.,LTD.

  2023-06-12

• 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

• 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

• 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 (SL130) - The Attachable Delivery Unit (for ZEISS SL130) (hereafter called “attachable delivery unit”) is attached to the Carl Zeiss Meditec SL130 (hereafter called Zeiss SL130) to comprise a slit lamp delivery unit. The comprised scan slit lamp delivery unit is connected to the GYC-1000 to comprise aphotocoagulation system. The attachable delivery unit is mainly comprised of a photocoagulation unit and a protective filter unit.

  NIDEK CO.,LTD.

  2017-02-01

• 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

• BIO delivery unit (Keeler) - This unit is connected to the NIDEK GREEN LASER DIODE PHOTOCOAGULATOR, Model GYC-1000 (main body) to comprise the photocoagulation system and applied to the treatment of the affected area using the B.I.O. (HEINE OMEGA 180 TYPE). The comprised photocoagulation system makes it possible to select between photocoagulation with the green laser beam (wavelength: 532 nm) and observation with the B.I.O..

  NIDEK CO.,LTD.

  2017-02-03

• BIO delivery unit (Heine OMEGA) - This unit is connected to the NIDEK GREEN LASER PHOTOCOAGULATOR, Model GYC- 1000 (main body) to comprise the photocoagulation system and applied to the treatment of the affected area using the B.I.O. delivery unit (HEINE OMEGA 500). The comprised photocoagulation system makes it possible to switch between photocoagulation with the green laser beam (wavelength: 532 nm) and observation with the B.I.O.

  NIDEK CO.,LTD.

  2017-02-03

• Dual delivery unit - This dual delivery unit is used in connection with the green laser photocoagulator GYC-1000. Using this unit enables connection of two types of delivery units to a unit of GYC-1000. The desired connected delivery unit can be selected and used with easy switching.

  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

• 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

• 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

• DIGITAL MEDICAL SCOPE - NIDEK DS-10F is a digital hand-held eye-fundus camera used to record digital photographs and video of fundus (including retina, macula and optic disc) of the human eye and surrounding area.

  NIDEK CO.,LTD.

  2016-09-13

• DIGITAL MEDICAL SCOPE - NIDEK DS-20 is a digital hand-held eye-fundus camera used to record digital photographs and video of fundus (including retina, macula and optic disc) of the human eye and surrounding area.

  NIDEK CO.,LTD.

  2017-01-27

• DIGITAL MEDICAL SCOPE - DS-10A is a digital hand-held anterior scope used to record digital photographs and video of anterior area of the human eye and surrounding area.

  NIDEK CO.,LTD.

  2017-01-27

• DIGITAL MEDICAL SCOPE - DS-10D is a digital hand-held dermatoscope used to record digital photographs and video of the human skin.

  NIDEK CO.,LTD.

  2017-01-31

• DIGITAL MEDICAL SCOPE - DS-10E is a digital hand-held otoscope used to record digital photographs and video of the human ear’s canal and tympanic membrane.

  NIDEK CO.,LTD.

  2017-01-31

• DIGITAL MEDICAL SCOPE - DS-10G is a digital hand-held camera used to record digital photographs and video of the human body.

  NIDEK CO.,LTD.

  2017-01-31

• DIGITAL 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.

  NIDEK CO.,LTD.

  2017-01-31

• DIGITAL 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.

  NIDEK CO.,LTD.

  2017-01-31

• DIGITAL MEDICAL SCOPE - NIDEK DS-20 is a digital hand-held eye-fundus camera used to record digital photographs and video of fundus (including retina, macula and optic disc) of the human eye and surrounding area. DS-20 consists of control unit and optical lens DS-20F (Digital Eye Fundus Camera).

  NIDEK CO.,LTD.

  2017-01-31

• Slit Lamp - The NIDEK SLIT LAMP SL-2000 is used to magnify the eyeball, eyelid, and eyelash of patients for observation, using slit illumination light.

  NIDEK CO.,LTD.

  2017-07-03

• 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

• Open-field Refraction System - The PHANTOM is a device that performs objective refraction and subjective refraction for the patient's eyes.

  NIDEK CO.,LTD.

  2026-01-08

• Open-field Refraction System - Control Box is a combined examination device that presents optical targets for both distant and near vision acuity testing, and performs objective and subjective refraction measurements of the examinee’s eye.

  NIDEK CO.,LTD.

  2026-01-08

• A-scan probe - It is used to scan axial length with the ultrasonic measurement function which equipped with the OPTICAL BIOMETER AL-Scan.

  NIDEK CO.,LTD.

  2023-07-10

• Pachymetry probe (45° fixed type) - It is used to scan corneal thickness with the ultrasonic measurement function which equipped with the OPTICAL BIOMETER AL-Scan.

  NIDEK CO.,LTD.

  2023-07-10

• A-scan probe - It is used to scan axial length with the ultrasonic measurement function which equipped with the ECHOSCAN US-4000.

  NIDEK CO.,LTD.

  2023-07-10

• Pachymetry probe - It is used to scan corneal thickness with the ultrasonic measurement function which equipped with the ECHOSCAN US-4000.

  NIDEK CO.,LTD.

  2023-07-10

• Pachymetry probe (45° fixed type) - It is used to scan corneal thickness with the ultrasonic measurement function which equipped with the ECHOSCAN US-4000.

  NIDEK CO.,LTD.

  2023-07-10

• A-scan probe - It is used to scan axial length with the ultrasonic measurement function which equipped with the ECHOSCAN US-500.

  NIDEK CO.,LTD.

  2023-07-10

• IOL-Station - The IOL-Station software acquires examination data from the NIDEK Refractive Power / Corneal Analyzer model OPD-Scan III, Optical Biometer AL-Scan, and Specular Microscope CEM-530, and offers functions such as IOL power calculation, aspheric IOL recommendation, simulation of patient's view with IOL, and printing of Cataract Summary. It provides data required for cataract surgery and helps explanations to the patients.

  NIDEK CO.,LTD.

  2023-07-10

• IOL-Station - The IOL-Station software acquires examination data from the NIDEK Refractive Power / Corneal Analyzer model OPD-Scan III, Optical Biometer AL-Scan, and Specular Microscope CEM-530, and offers functions such as IOL power calculation, aspheric IOL recommendation, simulation of patient's view with IOL, and printing of Cataract Summary. It provides data required for cataract surgery and helps explanations to the patients.

  NIDEK CO.,LTD.

  2023-06-12

• MICROPERIMETER - The NIDEK MICROPERIMETER, MP-3 measures the visual sensitivity of a specified area on the fundus according to the patient’s response, and captures color fundus images. The fundus image overlaid with the retinal sensitivity mapping is displayed on the screen for fundus-image-correlated evaluation. With reference to the Microperimeter MP-3, a rehabilitation function and the capability to performs exams in scotopic environments (only MP-3 type S) have been added.

  NIDEK CO.,LTD.

  2023-06-12

• REFRACTOR - NIDEK Model RT-600 has been developed to renovate the conventional refractor, assuming a new aspect, to turn the thought of the people who used the conventional model, to an entirely different subjective refractor, easy to master with the highest accuracy.

  NIDEK CO.,LTD.

  2023-06-12

• Image filing software NAVIS-EX - The NAVIS-EX image filing software is software that acquires data from the following NIDEK fundus photography devices and files it for easy transfer to external systems. NAVIS-EX is equipped with functions for image acquiring, image display, image drawing, image processing, image measurement, panorama image creation, stereo image observation, composite image creation, and Follow-Up. (According to the image, available functions are limited.) Image data can be transferred by network or e-mail. NAVIS-EX can construct a network among multiple terminals and refers to and edits data from the clientPC.

  NIDEK CO.,LTD.

  2023-06-12

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