NIDEK CO.,LTD.

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

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Device Description : The NIDEK AUTO REF/KERATOMETER ARK-1s measures spherical, cylindrical refractive The NIDEK AUTO REF/KERATOMETER ARK-1s measures spherical, cylindrical refractive errors, and cylinder axis from the refractive status of the patient’s eye. In addition, subjective test is performed with the built-in charts and lenses for subjective measurement. The keratometer measures the corneal curvature radius (corneal refractive power), principal meridian directions, and corneal cylindrical power.

Device Class : 1

Duns Number: 690635461

Premarket Exempt : Yes

Product Code : HLQ, HKO

Prescription Use : No

Device Count : 1

Device Description : The NIDEK AUTO REF/KERATOMETER ARK-1s measures spherical, cylindrical refractive The NIDEK AUTO REF/KERATOMETER ARK-1s measures spherical, cylindrical refractive errors, and cylinder axis from the refractive status of the patient’s eye. In addition, subjective test is performed with the built-in charts and lenses for subjective measurement. The keratometer measures the corneal curvature radius (corneal refractive power), principal meridian directions, and corneal cylindrical power.

Device Class : 1

Duns Number: 690635461

Premarket Exempt : Yes

Product Code : HKO, HLQ

Prescription Use : Yes

Device Count : 1

Device Description : The NIDEK HANDHELD REFRACTOMETER, HandyRef, measures spherical, cylindrical refr The NIDEK HANDHELD REFRACTOMETER, HandyRef, measures spherical, cylindrical refractive errors, and cylinder axis from the refractive status of the patient’s eye.This device is a hand-held model that allows measurement of children who cannot hold their head on the stationary chinrest, bed-ridden patients or patients in an operating room.

Device Class : 1

Duns Number: 690635461

Premarket Exempt : Yes

Product Code : HKO

Prescription Use : Yes

Device Count : 1

Device Description : The NIDEK HANDHELD REF/KERATOMETER, HandyRef-K, measures spherical, cylindrical The NIDEK HANDHELD REF/KERATOMETER, HandyRef-K, measures spherical, cylindrical refractive errors, and cylinder axis from the refractive status of the patient’s eye.The keratometer measures the corneal curvature radius (corneal refractive power) in the steepest and flattest meridian directions, cylinder axis, and corneal cylindrical power.This device is a hand-held model that allows measurement of children who cannot hold their head on the stationary chinrest, bed-ridden patients or patients in an operating room.

Device Class : 1

Duns Number: 690635461

Premarket Exempt : Yes

Product Code : HKO, HLQ

Prescription Use : Yes

Device Count : 1

Device Description : The NIDEK refractive power / corneal analyzer OPD-Scan III (hereafter referred t The NIDEK refractive power / corneal analyzer OPD-Scan III (hereafter referred to as “the device”) measures objective refractive error, corneal curvature, shape of the anterior corneal surface (topography), and pupil size of the patient’s eye, and analyzes wavefront aberration. The measured refractive error can be used for reference when prescribing corrective lenses such as glasses or contact lenses.

Device Class : 1

Duns Number: 690635461

Premarket Exempt : Yes

Product Code : HLQ, HKO

Prescription Use : Yes

Device Count : 1

Device Description : The ST-5100 is the system table on which the NIDEK REFRACTOR RT-5100 is installe The ST-5100 is the system table on which the NIDEK REFRACTOR RT-5100 is installed. The table allows the SSC-330/350, AR/ARK series, and LM-500/LM-600 series/LM-1800 series to be combined into an ophthalmic workstation. The table is composed of a refractor arm, motorized main table, and side table. The main table, which is electrically extendable up to 180 mm, has an RT arm, rotatable with one touch, simple operation, and a tray to hold an auto refractometer (AR/ARK series). The side table is for installing the SSC-330/350 or LM-500/LM-600 series/LM-1800 series. It is equipped with drawers for trial lenses and space for a computer and printer.

Device Class : 1

Duns Number: 690635461

Premarket Exempt : Yes

Product Code : HRJ

Prescription Use : No

Device Count : 1

- Catalog Number :

Device Description : The NIDEK REFRACTOR Model RT-3100 is a computerized refractor used for subjectiv The NIDEK REFRACTOR Model RT-3100 is a computerized refractor used for subjective refraction with the NIDEK AUTO REFRACTOMETER (AR), AUTO REF/KERATOMETER (ARK), AUTO REF/ KER/TONOMETER (RKT), or AUTO LENSMETER (LM) via Eye Care card. The RT-3100 includes a refractor head, control box, and relay box. The relay box not only connects the other two units, but also connects the Chart Presenting device or PC. The control box includes the key panel, display, and printer. The display is a touch-screen panel. The control box displays the data and can be used for almost all operations. In addition, the control box operates the refractor head and the connected chart presenting device. It allows the refractor and charts to be controlled together. Normally, the relay box is installed on the system table (not included in the RT-3100 package.)

Device Class : 1

Duns Number: 690635461

Premarket Exempt : Yes

Product Code : HKN

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : The NIDEK REFRACTOR Model RT-5100 is a computerized refractor used for subjectiv The NIDEK REFRACTOR Model RT-5100 is a computerized refractor used for subjective refraction in connection with the NIDEK AUTO REFRACTOMETER (AR), AUTO REF/KERATOMETER (ARK), AUTO REF/KER/TONOMETER (RKT), or AUTO LENSMETER (LM). The RT-5100 includes a refractor head, control box, relay box, and printer.

Device Class : 1

Duns Number: 690635461

Premarket Exempt : Yes

Product Code : HKN

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : The PD meter model PM-700 is a pupillary distance meter improved with a built-in The PD meter model PM-700 is a pupillary distance meter improved with a built-in computer and LCD digital display.

Device Class : 1

Duns Number: 690635461

Premarket Exempt : Yes

Product Code : HLG

Prescription Use : Yes

Device Count : 1

Device Description : The NIDEK Green Laser Photocoagulator GYC-500 is a laser photocoagulator for oph The NIDEK Green Laser Photocoagulator GYC-500 is a laser photocoagulator for ophthalmology using a 532 nm diode-pumped solid-state laser (green laser beam) as the treatment beam source. The device incorporates a diode-pumped laser that enables efficient laser beam emission at 532 nm. For the laser beam delivery, various types of delivery units may be employed. This allows performance of transpupillary photocoagulation using a slit lamp or binocular indirect ophthalmoscope.

Device Class : 2

Duns Number: 690635461

Premarket Exempt : No

Product Code : HQF

Prescription Use : Yes

Device Count : 1