NIDEK CO.,LTD.

Address:34-14 MAEHAMA, HIROISHI-CHO,GAMAGORI, AICHI,JP

Want to know more about this Organization? Request more information now!


Filters
Device Class
Product Code
Premarket Exempt
Clear
- Catalog Number :

Device Description : NIDEK EXCIMER LASER CORNEAL SURGERY SYSTEM, model EC-5000CXIII, is an ophthalmic NIDEK EXCIMER LASER CORNEAL SURGERY SYSTEM, model EC-5000CXIII, is an ophthalmic laser system used for correction of corneal refraction and ablation of the corneal surface. The system is composed of a laser generator which produces an excimer laser radiation of wavelength193nm, a beam delivery unit, an optical system for observation, a gas system, and a computer for system control. The system is designed to be user friendly for easy and safe operation with NIDEK’s advanced optoelectronic technology.

Device Class : 3

Duns Number: 690635461

Premarket Exempt : No

Product Code : LZS

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : NIDEK EXCIMER LASER CORNEAL SURGERY SYSTEM, model Quest, is an ophthalmic laser NIDEK EXCIMER LASER CORNEAL SURGERY SYSTEM, model Quest, is an ophthalmic laser system used for correction of corneal refraction and ablation of the corneal surface. The system is composed of a laser generator which produces an excimer laser radiation of wavelength 193nm, a beam delivery unit, an optical system for observation, a gas system, and a computer for system control. The system is designed to be user friendly for easy and safe operation with NIDEK’s advanced optoelectronic technology.

Device Class : 3

Duns Number: 690635461

Premarket Exempt : No

Product Code : LZS

Prescription Use : Yes

Device Count : 1

Device Description : The Final Fit software receives the measured data from the Refractive Power/Corn The Final Fit software receives the measured data from the Refractive Power/Corneal Analyzer OPD-Scan Model ARK-10000 via floppy disk etc. Then the Final Fit software performs a simulation of postoperative corneal shape and generates shot data using the imported data that was measured by the ARK-10000 and amounts of correction that are entered. The Final Fit software has two major functions: 1.Generating shot data to be used with the EC-5000 based on the measured data of the ARK-10000 2.Comparing postoperative data measured by ARK-10000 with the preoperative or target data (Simulated data just before generating shot data)

Device Class : 3

Duns Number: 690635461

Premarket Exempt : No

Product Code : LZS

Prescription Use : Yes

Device Count : 1

Device Description : The Final Fit software receives the measured data from the Refractive Power/Corn The Final Fit software receives the measured data from the Refractive Power/Corneal Analyzer OPD-Scan Model ARK-10000 via floppy disk etc. Then the Final Fit software performs a simulation of postoperative corneal shape and generates shot data using the imported data that was measured by the ARK-10000 and amounts of correction that are entered. The Final Fit software has two major functions: 1.Generating shot data to be used with the EC-5000 based on the measured data of the ARK-10000 2.Comparing postoperative data measured by ARK-10000 with the preoperative or target data (Simulated data just before generating shot data)

Device Class : 3

Duns Number: 690635461

Premarket Exempt : No

Product Code : LZS

Prescription Use : Yes

Device Count : 1

Device Description : The NIDEK Chart Projector CP-770 is a test chart presenting device which can ach The NIDEK Chart Projector CP-770 is a test chart presenting device which can achieve refraction distance from 2.9 m to 6.1 m. The device is controlled by a wireless remote control or a control box on the refractor (RT).The CP-770 features the following:• Equipped with 33 types of charts (27 types for Type UK) including various kinds of binocular charts• Program function that allows chart presentation with the touch of a button• Versatile masking function that can even offer the display of even a single character• Chart brightness adjustability to the installation conditions• Switchable function between display and non-display of visual acuity of the chart• A long-life LED for the illumination light source

Device Class : 1

Duns Number: 690635461

Premarket Exempt : Yes

Product Code : HOX

Prescription Use : Yes

Device Count : 1

Device Description : AUTO REF/KERATO/TONOMETER Model TONOREF II is designed to singly perform objecti AUTO REF/KERATO/TONOMETER Model TONOREF II is designed to singly perform objective refraction, corneal shape measurement, and non-contact tonometry measurement by incorporating a standard auto ref/keratometer and non-contact tonometer into one unit. The objective refraction function measures spherical powers, cylindrical powers and cylinder axis. The corneal shape measurement function measures the radius of corneal curvature (corneal refractive powers), the direction of the steepest meridian, and the amount of corneal astigmatism. The non-contact tonometry function measures the intraocular pressure without contacting the eye.

Device Class : 1

Duns Number: 690635461

Premarket Exempt : No

Product Code : HKX, HKO, HLQ

Prescription Use : Yes

Device Count : 1

Device Description : The ophthalmic YAG laser system YC-1800 emits Nd: YAG laser (hereafter called “Y The ophthalmic YAG laser system YC-1800 emits Nd: YAG laser (hereafter called “YAG laser”) pulse beam by Q-switching. The YC-1800 allows the safe and bloodless treatment of intraocular diseases for outpatients by mechanical disruption caused by energy of the YAG laser pulses. The main purposesof the YC-1800 are posterior capsulotomy for secondary cataract, iridotomy for acute angle-closure glaucoma, and for pupillary membranectomy for traction retinal detachment. The YC-1800 has a slit lamp for observation that includes the YAG laser and its controlling mechanism. The YC-1800 is also equipped with an operation panel and knobs that facilitate operation. The compact and lightweight power supply box is installed separately for lightness and compactness of the system. In addition, a motorized table for the YC-1800 is available optionally.

Device Class : 2

Duns Number: 690635461

Premarket Exempt : No

Product Code : LXS

Prescription Use : Yes

Device Count : 1

Device Description : The NIDEK Multicolor Laser Photocoagulator MC-500 is a laser photocoagulator for The NIDEK Multicolor Laser Photocoagulator MC-500 is a laser photocoagulator for ophthalmology with the light source of wavelengths 647, 577, and 532 nm. As the conventional laser photocoagulators, the MC-500 can be used for retinal photocoagulation for treatment of ocular fundus diseases like diabetic retinopathy, age-related macular degeneration, retinopathy of prematurity, and retinal detachment, or for laser iridotomy and laser trabeculoplasty for treatment of glaucoma. The device incorporates two types of lasers (diode-pumped solid state laser and laser diode) which enable efficient obtainment of laser beam oscillation of each wavelength. As the conventional device, various types of laser delivery units can be used. Therefore, transpupillary photocoagulation can be performed using various delivery units such as slit lamps and binocular indirect ophthalmoscope.

Device Class : 2

Duns Number: 690635461

Premarket Exempt : No

Product Code : HQF

Prescription Use : Yes

Device Count : 1

Device Description : This delivery unit is connected to the NIDEK Multicolor Laser Photocoagulator, M This delivery unit is connected to the NIDEK Multicolor Laser Photocoagulator, Model MC-500 main body to comprise the photocoagulation system and to treat affected areas using the slit lamp, NIDEK SL-1800. A slit lamp delivery unit that includes the SL-1800 comprises a photocoagulation system in connection with the MC-500 main body.

Device Class : 2

Duns Number: 690635461

Premarket Exempt : No

Product Code : HQF

Prescription Use : Yes

Device Count : 1

Device Description : This combination delivery unit is need to comprise the combination system which This combination delivery unit is need to comprise the combination system which enables radiation of the red, yellow, or 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 Multicolor Laser Photocoagulator MC-500 using the MC connecting cable and fiber optic cable. The combination system allows selection between photocoagulation with the red (647 nm), yellow (577 nm), or green (532 nm) laser beam and YAG laser beam (wavelength: 1064 nm (pulse laser)). In addition, they are selected easily by changing the optical path of the laser beam with the laser selectlever, and various kinds of safety devices are integrated into the system to make sure that only the selected laser beam is radiated. This combination delivery unit is the only delivery unit that can be connected both to the NIDEK Multicolor Laser Photocoagulator MC-500 and the NIDEK Ophthalmic YAG Laser System YC-1800.

Device Class : 2

Duns Number: 690635461

Premarket Exempt : No

Product Code : HQF

Prescription Use : Yes

Device Count : 1