# Nidek, Inc.

> Medical device manufacturer record on deviCERTS, compiled from public registries. 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 15 Nov 2026.

- Canonical page: <https://devicerts.com/manufacturers/nidek-inc>
- Country: United States (FDA applicant, unverified)
- Role: Manufacturer, Part of a group

## Figures

- Devices: 78
- FDA recalls (matched to the firm by name): 0

## Registry facts

*Every device of the manufacturer. A device listed in two registries counts in both.*

- Registries: FDA 510(k) 77, FDA PMA 1
- Device classes: FDA Class II 61, FDA Class I 15, FDA Class III 2

## Sites and related companies

- Part of [Nidek Co., Ltd.](https://devicerts.com/manufacturers/nidek-co-ltd)

## Devices

The first 50 of 78, in the order of the canonical page, which lists them all.

- [Auto Refractometer](https://devicerts.com/devices/auto-refractometer-hko) · ref K831083 · Class I · 510(k) · status: Active · decision 1983-06-10
- [Ar-1100 Automatic Refractor](https://devicerts.com/devices/ar-1100-automatic-refractor-hko) · ref K861065 · Class I · 510(k) · status: Active · decision 1986-04-09
- [Prima Ktp Laser System](https://devicerts.com/devices/prima-ktp-laser-system-gex) · ref K973828 · Class II · 510(k) · status: Active · decision 1998-01-05
- [Nidek Models Ac-2100 & 2200](https://devicerts.com/devices/nidek-models-ac-2100-and-2200-gex) · ref K913465 · Class II · 510(k) · status: Active · decision 1991-10-21
- [Nidek Prima Model Gyc-1500/2000](https://devicerts.com/devices/nidek-prima-model-gyc-1500-2000-gex) · ref K980547 · Class II · 510(k) · status: Active · decision 1998-05-13
- [Anterior Eye-Segment Analysis System](https://devicerts.com/devices/anterior-eye-segment-analysis-system-mxk) · ref K991284 · Class II · 510(k) · status: Active · decision 1999-08-06
- [Nidek-Binocular Indirect Ophthalmoscope](https://devicerts.com/devices/nidek-binocular-indirect-ophthalmoscope-hli) · ref K843596 · Class II · 510(k) · status: Active · decision 1985-02-15
- [Nidek Cv-4000](https://devicerts.com/devices/nidek-cv-4000-hqe) · ref K880929 · Class II · 510(k) · status: Active · decision 1988-05-25
- [Non-Contact Tonometer, Model Nt-4000](https://devicerts.com/devices/non-contact-tonometer-model-nt-4000-hkx) · ref K031733 · Class II · 510(k) · status: Active · decision 2003-12-04
- [Nidek Us-2000](https://devicerts.com/devices/nidek-us-2000-iyo) · ref K903326 · Class II · 510(k) · status: Active · decision 1990-11-21
- [Nidek, Inc. Model Adc-8000 Derm](https://devicerts.com/devices/nidek-inc-model-adc-8000-derm-gex) · ref K900925 · Class II · 510(k) · status: Active · decision 1990-09-10
- [Nidek Lm-870 Automatic Lensmeter](https://devicerts.com/devices/nidek-lm-870-automatic-lensmeter-hlm) · ref K884188 · Class I · 510(k) · status: Active · decision 1988-11-23
- [Microkeratome, Model Mk-2000](https://devicerts.com/devices/microkeratome-model-mk-2000-hno) · ref K990900 · Class I · 510(k) · status: Active · decision 1999-09-24
- [Nidek Cyberscan](https://devicerts.com/devices/nidek-cyberscan-gex) · ref K970017 · Class II · 510(k) · status: Active · decision 1997-03-18
- [Nidek Model Akc-8000](https://devicerts.com/devices/nidek-model-akc-8000-hqf) · ref K894273 · Class II · 510(k) · status: Active · decision 1989-08-07
- [Nidek Opeating Microscope Delivery System (Omds)](https://devicerts.com/devices/nidek-opeating-microscope-delivery-system-omds-hqf) · ref K883213 · Class II · 510(k) · status: Active · decision 1988-09-15
- [Nidek Us-1600 A-Scan](https://devicerts.com/devices/nidek-us-1600-a-scan-iyo) · ref K854389 · Class II · 510(k) · status: Active · decision 1986-04-08
- [Nidek Model Gyc-1500 And Gyc-2000](https://devicerts.com/devices/nidek-model-gyc-1500-and-gyc-2000-hqf) · ref K951079 · Class II · 510(k) · status: Active · decision 1995-09-14
- [Dc-3300 Laser Diode Photocoagulator](https://devicerts.com/devices/dc-3300-laser-diode-photocoagulator-hqf) · ref K013760 · Class II · 510(k) · status: Active · decision 2002-02-11
- [Model Yc-1200/Photocoagulator Ophthalmic Laser](https://devicerts.com/devices/model-yc-1200-photocoagulator-ophthalmic-laser-gex) · ref K901481 · Class II · 510(k) · status: Active · decision 1990-06-20
- [Nidek Model Vt-4000, Modification](https://devicerts.com/devices/nidek-model-vt-4000-modification-hqe) · ref K936302 · Class II · 510(k) · status: Active · decision 1994-07-15
- [Sun Photo-Keratoscope](https://devicerts.com/devices/sun-photo-keratoscope-hlq) · ref K831084 · Class I · 510(k) · status: Active · decision 1983-06-30
- [Argon/Krypton & Krypton Laser Photocoagulation Sys](https://devicerts.com/devices/argon-krypton-and-krypton-laser-photocoagulation-sys-hqb) · ref K844197 · Class II · 510(k) · status: Active · decision 1984-12-24
- [Nidek Model Nt-1000](https://devicerts.com/devices/nidek-model-nt-1000-hkx) · ref K913189 · Class II · 510(k) · status: Active · decision 1991-10-15
- [Omron Ultrasonic Nebulizer Ne-U06](https://devicerts.com/devices/omron-ultrasonic-nebulizer-ne-u06-caf) · ref K875134 · Class II · 510(k) · status: Active · decision 1988-12-05
- [Nidek Advanced Vision Information System (Navis)](https://devicerts.com/devices/nidek-advanced-vision-information-system-navis-nfj) · ref K013694 · Class II · 510(k) · status: Active · decision 2002-11-19
- [Nidek Up-2000](https://devicerts.com/devices/nidek-up-2000-iyo) · ref K880065 · Class II · 510(k) · status: Active · decision 1988-03-15
- [Nidek Cv-12000](https://devicerts.com/devices/nidek-cv-12000-hqc) · ref K924260 · Class II · 510(k) · status: Active · decision 1993-03-26
- [Argon Laser Photocoagulator Sys Repeat Mode](https://devicerts.com/devices/argon-laser-photocoagulator-sys-repeat-mode-hqb) · ref K844198 · Class II · 510(k) · status: Active · decision 1984-12-24
- [Ar-1600 Automatic Refractor](https://devicerts.com/devices/ar-1600-automatic-refractor-hko) · ref K861062 · Class I · 510(k) · status: Active · decision 1986-04-04
- [Ar-1000 Automatic Refractor](https://devicerts.com/devices/ar-1000-automatic-refractor-hko) · ref K861066 · Class I · 510(k) · status: Active · decision 1986-04-04
- [Nidek, Inc. Bio-Dc Laser Delivery System](https://devicerts.com/devices/nidek-inc-bio-dc-laser-delivery-system-gex) · ref K900165 · Class II · 510(k) · status: Active · decision 1990-03-22
- [Nidek/Phaco Emulsification System Model Cv-8000](https://devicerts.com/devices/nidek-phaco-emulsification-system-model-cv-8000-hqc) · ref K901686 · Class II · 510(k) · status: Active · decision 1990-06-08
- [Nidek Adc-8000 Laser System](https://devicerts.com/devices/nidek-adc-8000-laser-system-hqf) · ref K872846 · Class II · 510(k) · status: Active · decision 1987-10-15
- [Nidek Ar-1200](https://devicerts.com/devices/nidek-ar-1200-hko) · ref K890559 · Class I · 510(k) · status: Active · decision 1989-02-27
- [Nidek Model Yc-1200](https://devicerts.com/devices/nidek-model-yc-1200-lxs) · ref K893987 · Class II · 510(k) · status: Active · decision 1989-08-18
- [Nidek Inc. Models Yc-2000 & 3000 Ophthalmic Lasers](https://devicerts.com/devices/nidek-inc-models-yc-2000-and-3000-ophthalmic-lasers-lxs) · ref K892204 · Class II · 510(k) · status: Active · decision 1989-06-22
- [Nidek Us-3000](https://devicerts.com/devices/nidek-us-3000-iyo) · ref K882162 · Class II · 510(k) · status: Active · decision 1988-08-19
- [Epi-Star Surgical Laser Syster](https://devicerts.com/devices/epi-star-surgical-laser-syster-gex) · ref K990119 · Class II · 510(k) · status: Active · decision 2000-07-27
- [Nidek Model Adc-8000](https://devicerts.com/devices/nidek-model-adc-8000-gex) · ref K894709 · Class II · 510(k) · status: Active · decision 1989-10-04
- [Nidek Model Akc-8000 Ophthalmic Laser Photocoagula](https://devicerts.com/devices/nidek-model-akc-8000-ophthalmic-laser-photocoagula-gex) · ref K900890 · Class II · 510(k) · status: Active · decision 1990-09-10
- [Nidek Digital Keratometer](https://devicerts.com/devices/nidek-digital-keratometer-hql) · ref K842892 · Class III · 510(k) · status: Active · decision 1984-10-05
- [Multi Color Laser Photocoagulator, Model Mc-300](https://devicerts.com/devices/multi-color-laser-photocoagulator-model-mc-300-gex) · ref K042785 · Class II · 510(k) · status: Active · decision 2004-12-14
- [Nidek Km-1000 Surgical Keratometer](https://devicerts.com/devices/nidek-km-1000-surgical-keratometer-hlq) · ref K862137 · Class I · 510(k) · status: Active · decision 1986-07-23
- [Ar-1600g Auto-Refractometer](https://devicerts.com/devices/ar-1600g-auto-refractometer-hko) · ref K902500 · Class I · 510(k) · status: Active · decision 1990-07-27
- [Nidek Km-800 Auto Keratometer](https://devicerts.com/devices/nidek-km-800-auto-keratometer-hlq) · ref K861063 · Class I · 510(k) · status: Active · decision 1986-04-04
- [Nidek Ac-2000 Laser System](https://devicerts.com/devices/nidek-ac-2000-laser-system-hqb) · ref K860011 · Class II · 510(k) · status: Active · decision 1986-02-07
- [Nidek Multi Color Laser Photocoagulator, Model Mc-7000](https://devicerts.com/devices/nidek-multi-color-laser-photocoagulator-model-mc-7000-gex) · ref K974732 · Class II · 510(k) · status: Active · decision 1998-03-18
- [Nidek Model Vst-4000](https://devicerts.com/devices/nidek-model-vst-4000-hqe) · ref K924353 · Class II · 510(k) · status: Active · decision 1993-03-29
- [Monocular Direct Ophthalmoscope](https://devicerts.com/devices/monocular-direct-ophthalmoscope-hli) · ref K844971 · Class II · 510(k) · status: Active · decision 1985-02-15

## Source and citation

- Cite as: Nidek, Inc. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/nidek-inc (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [FDA PMA](https://open.fda.gov/apis/device/pma/)
- FDA recall data as of: 2026-11-01
- Data as of: 2026-11-15
- JSON: <https://devicerts.com/manufacturers/nidek-inc.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/manufacturers/nidek-inc
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.