NIDEK CO.,LTD.

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

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- Catalog Number :

Device Description : The F-10 captures and records the confocal images of fundus by laser scanning us The F-10 captures and records the confocal images of fundus by laser scanning using a selection of laser colors: IR (infrared), blue, green, and red. Indocyanine green (ICG) angiography and fluorescein angiography (FAG) are also possible.

Device Class : 2

Duns Number: 690635461

Premarket Exempt : No

Product Code : MYC

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : The NIDEK AUTO LENSMETER LM-1800P/LM-1800PD measures the optical performance of The NIDEK AUTO LENSMETER LM-1800P/LM-1800PD measures the optical performance of spectacle lenses such as single vision, bifocal (trifocal), and progressive power lenses or contact lenses. This device has a measuring unit and a display unit in front, and a printer unit on the right side.

Device Class : 1

Duns Number: 690635461

Premarket Exempt : Yes

Product Code : HLM

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : The NIDEK AUTO LENSMETER LM-1800P/LM-1800PD measures the optical performance of The NIDEK AUTO LENSMETER LM-1800P/LM-1800PD measures the optical performance of spectacle lenses such as single vision, bifocal (trifocal), and progressive power lenses or contact lenses. This device has a measuring unit and a display unit in front, and a printer unit on the right side.

Device Class : 1

Duns Number: 690635461

Premarket Exempt : Yes

Product Code : HLM

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : The space saving chart SSC-370 achieves the refraction distance of 5 m within an The space saving chart SSC-370 achieves the refraction distance of 5 m within an installation distance*1 of 1.1 m. The SSC-370 is a chart presenting device. The built-in optical system presents charts toward the back of the chart window. The VA (visual acuity) charts are composed of the four types of letters, Tumbling E, number, and children.

Device Class : 1

Duns Number: 690635461

Premarket Exempt : Yes

Product Code : HOX

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : The SYSTEM CHART SC-1600 is a chart presenting device that displays the charts o The SYSTEM CHART SC-1600 is a chart presenting device that displays the charts on an LCD. The charts are controlled by an optional remote control or the control box of the NIDEK refractor*1. In contrast to a chart presenting device which projects the charts from film, the SC-1600 displays the digitally stored chart shapes on the LCD. This makes the following possible.

Device Class : 1

Duns Number: 690635461

Premarket Exempt : Yes

Product Code : HOX

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : The NIDEK AUTO REFRACTOMETER AR-1a/AR-1 measures spherical, cylindrical refracti The NIDEK AUTO REFRACTOMETER AR-1a/AR-1 measures spherical, cylindrical refractive errors, and cylinder axis from the refractive status of the patient’s eye.

Device Class : 1

Duns Number: 690635461

Premarket Exempt : Yes

Product Code : HKO

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : The NIDEK AUTO REFRACTOMETER AR-1a/AR-1 measures spherical, cylindrical refracti The NIDEK AUTO REFRACTOMETER AR-1a/AR-1 measures spherical, cylindrical refractive errors, and cylinder axis from the refractive status of the patient’s eye.

Device Class : 1

Duns Number: 690635461

Premarket Exempt : Yes

Product Code : HKO

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : The NIDEK AUTO REFRACTOMETER AR-1s measures spherical, cylindrical refractive er The NIDEK AUTO REFRACTOMETER AR-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.

Device Class : 1

Duns Number: 690635461

Premarket Exempt : Yes

Product Code : HKO

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : The NIDEK AUTO REF/KERATOMETER ARK-1a/ARK-1 measures spherical, cylindrical refr The NIDEK AUTO REF/KERATOMETER ARK-1a/ARK-1 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), 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

- Catalog Number :

Device Description : The NIDEK AUTO REF/KERATOMETER ARK-1a/ARK-1 measures spherical, cylindrical refr The NIDEK AUTO REF/KERATOMETER ARK-1a/ARK-1 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), 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