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Nidek, Inc.

United StatesFDA applicant, unverified

Part of Nidek Co., Ltd.

Nidek, Inc. is a medical device manufacturer, with 78 devices listed in FDA 510(k) and FDA PMA (FDA Class II, I and III) as of 14 Nov 2026.

Devices
78

Registry facts

Counted by deviCERTS from registry records, 14 Nov 2026

Registries
  • FDA 510(k) 77
  • FDA PMA 1

A device listed in two registries counts in both.

Device classes
  • FDA Class II 61
  • FDA Class I 15
  • FDA Class III 2
Sites and related companies

What Nidek, Inc. makes

Nidek, Inc. manufactures ophthalmic diagnostic and treatment devices, including solid-state laser systems for surgical procedures, excimer lasers for eye corrections, and digital imaging tools like fundus cameras and dermatoscopes. Their portfolio also includes anterior segment analysers, ultrasound imaging systems for ocular assessments, and bench-top keratometers for corneal measurements. Additional products include laser beam guides, endophotocoagulation units, and A-scan probes for ocular biometry.

The company’s devices are regulated under FDA classifications, including Class I, Class II, and Class III, with submissions recorded in the 510(k), PMA, and UDI registries. These products are listed in the United States, where Nidek, Inc. is based.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue78

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Frequently asked questions

How many devices does Nidek, Inc. have in the registry?

The registry currently lists 78 devices for Nidek, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Nidek, Inc.'s devices?

Among its 50 most recently registered devices, Nidek, Inc. has devices listed in FDA 510(k) (50 devices).

What risk classes do Nidek, Inc.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for Nidek, Inc.'s devices are Class I, Class II and Class III. Each device page shows its own class and authorisation.

What are the newest devices from Nidek, Inc. in the registry?

The most recently registered devices listed for Nidek, Inc. include AUTO REFRACTOMETER, AR-1100 AUTOMATIC REFRACTOR, PRIMA KTP LASER SYSTEM and NIDEK MODELS AC-2100 & 2200.

Generated automatically from registry data and not verified by a human reviewer.