{
  "format": "devicerts.manufacturer.v1",
  "cite_as": "Nidek, Inc. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/nidek-inc (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/manufacturers/nidek-inc",
    "json_url": "https://devicerts.com/manufacturers/nidek-inc.json",
    "markdown_url": "https://devicerts.com/manufacturers/nidek-inc.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      },
      {
        "registry": "FDA PMA",
        "url": "https://open.fda.gov/apis/device/pma/"
      }
    ],
    "eudamed_record_synced": null,
    "fda_recalls_as_of": "2026-11-01",
    "registry_facts_computed": "2026-11-14",
    "status_as_of": "2026-11-15",
    "license": "CC BY 4.0",
    "license_url": "https://creativecommons.org/licenses/by/4.0/",
    "license_scope": "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",
    "disclaimer": "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."
  },
  "manufacturer": {
    "name": "Nidek, Inc.",
    "url": "https://devicerts.com/manufacturers/nidek-inc",
    "registered_as": null,
    "abbreviated_name": null,
    "also_registered_as": [],
    "country": "United States",
    "country_basis": "FDA applicant, unverified",
    "eudamed_status": null,
    "verified": false,
    "roles": [
      "Manufacturer",
      "Part of a group"
    ],
    "registrations": [],
    "identifiers": [],
    "summary": "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.",
    "noindex": false
  },
  "counts": {
    "devices": 78,
    "devices_note": null,
    "certificates": 0,
    "fda_recalls_matched_by_name": 0,
    "fda_recalls_ongoing": 0,
    "fda_recalls_ongoing_recent": 0,
    "fda_recalls_ongoing_before": null,
    "fda_establishments": 0,
    "sites": 0
  },
  "registry_facts": {
    "covers": "Every device of the manufacturer. A device listed in two registries counts in both.",
    "registries": [
      {
        "registry": "FDA 510(k)",
        "devices": 77
      },
      {
        "registry": "FDA PMA",
        "devices": 1
      }
    ],
    "device_classes": [
      {
        "class": "FDA Class II",
        "devices": 61
      },
      {
        "class": "FDA Class I",
        "devices": 15
      },
      {
        "class": "FDA Class III",
        "devices": 2
      }
    ],
    "top_emdn_categories": []
  },
  "related": {
    "site_of": null,
    "part_of": {
      "name": "Nidek Co., Ltd.",
      "url": "https://devicerts.com/manufacturers/nidek-co-ltd"
    },
    "sites": [],
    "authorised_representatives": []
  },
  "devices": {
    "shown": 50,
    "total": 78,
    "all_devices_url": "https://devicerts.com/manufacturers/nidek-inc",
    "items": [
      {
        "name": "Auto Refractometer",
        "url": "https://devicerts.com/devices/auto-refractometer-hko",
        "model_reference": "K831083",
        "device_class": "Class I",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1983-06-10",
        "open_recall": false
      },
      {
        "name": "Ar-1100 Automatic Refractor",
        "url": "https://devicerts.com/devices/ar-1100-automatic-refractor-hko",
        "model_reference": "K861065",
        "device_class": "Class I",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1986-04-09",
        "open_recall": false
      },
      {
        "name": "Prima Ktp Laser System",
        "url": "https://devicerts.com/devices/prima-ktp-laser-system-gex",
        "model_reference": "K973828",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1998-01-05",
        "open_recall": false
      },
      {
        "name": "Nidek Models Ac-2100 & 2200",
        "url": "https://devicerts.com/devices/nidek-models-ac-2100-and-2200-gex",
        "model_reference": "K913465",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1991-10-21",
        "open_recall": false
      },
      {
        "name": "Nidek Prima Model Gyc-1500/2000",
        "url": "https://devicerts.com/devices/nidek-prima-model-gyc-1500-2000-gex",
        "model_reference": "K980547",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1998-05-13",
        "open_recall": false
      },
      {
        "name": "Anterior Eye-Segment Analysis System",
        "url": "https://devicerts.com/devices/anterior-eye-segment-analysis-system-mxk",
        "model_reference": "K991284",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1999-08-06",
        "open_recall": false
      },
      {
        "name": "Nidek-Binocular Indirect Ophthalmoscope",
        "url": "https://devicerts.com/devices/nidek-binocular-indirect-ophthalmoscope-hli",
        "model_reference": "K843596",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1985-02-15",
        "open_recall": false
      },
      {
        "name": "Nidek Cv-4000",
        "url": "https://devicerts.com/devices/nidek-cv-4000-hqe",
        "model_reference": "K880929",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1988-05-25",
        "open_recall": false
      },
      {
        "name": "Non-Contact Tonometer, Model Nt-4000",
        "url": "https://devicerts.com/devices/non-contact-tonometer-model-nt-4000-hkx",
        "model_reference": "K031733",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2003-12-04",
        "open_recall": false
      },
      {
        "name": "Nidek Us-2000",
        "url": "https://devicerts.com/devices/nidek-us-2000-iyo",
        "model_reference": "K903326",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1990-11-21",
        "open_recall": false
      },
      {
        "name": "Nidek, Inc. Model Adc-8000 Derm",
        "url": "https://devicerts.com/devices/nidek-inc-model-adc-8000-derm-gex",
        "model_reference": "K900925",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1990-09-10",
        "open_recall": false
      },
      {
        "name": "Nidek Lm-870 Automatic Lensmeter",
        "url": "https://devicerts.com/devices/nidek-lm-870-automatic-lensmeter-hlm",
        "model_reference": "K884188",
        "device_class": "Class I",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1988-11-23",
        "open_recall": false
      },
      {
        "name": "Microkeratome, Model Mk-2000",
        "url": "https://devicerts.com/devices/microkeratome-model-mk-2000-hno",
        "model_reference": "K990900",
        "device_class": "Class I",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1999-09-24",
        "open_recall": false
      },
      {
        "name": "Nidek Cyberscan",
        "url": "https://devicerts.com/devices/nidek-cyberscan-gex",
        "model_reference": "K970017",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1997-03-18",
        "open_recall": false
      },
      {
        "name": "Nidek Model Akc-8000",
        "url": "https://devicerts.com/devices/nidek-model-akc-8000-hqf",
        "model_reference": "K894273",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1989-08-07",
        "open_recall": false
      },
      {
        "name": "Nidek Opeating Microscope Delivery System (Omds)",
        "url": "https://devicerts.com/devices/nidek-opeating-microscope-delivery-system-omds-hqf",
        "model_reference": "K883213",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1988-09-15",
        "open_recall": false
      },
      {
        "name": "Nidek Us-1600 A-Scan",
        "url": "https://devicerts.com/devices/nidek-us-1600-a-scan-iyo",
        "model_reference": "K854389",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1986-04-08",
        "open_recall": false
      },
      {
        "name": "Nidek Model Gyc-1500 And Gyc-2000",
        "url": "https://devicerts.com/devices/nidek-model-gyc-1500-and-gyc-2000-hqf",
        "model_reference": "K951079",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1995-09-14",
        "open_recall": false
      },
      {
        "name": "Dc-3300 Laser Diode Photocoagulator",
        "url": "https://devicerts.com/devices/dc-3300-laser-diode-photocoagulator-hqf",
        "model_reference": "K013760",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2002-02-11",
        "open_recall": false
      },
      {
        "name": "Model Yc-1200/Photocoagulator Ophthalmic Laser",
        "url": "https://devicerts.com/devices/model-yc-1200-photocoagulator-ophthalmic-laser-gex",
        "model_reference": "K901481",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1990-06-20",
        "open_recall": false
      },
      {
        "name": "Nidek Model Vt-4000, Modification",
        "url": "https://devicerts.com/devices/nidek-model-vt-4000-modification-hqe",
        "model_reference": "K936302",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1994-07-15",
        "open_recall": false
      },
      {
        "name": "Sun Photo-Keratoscope",
        "url": "https://devicerts.com/devices/sun-photo-keratoscope-hlq",
        "model_reference": "K831084",
        "device_class": "Class I",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1983-06-30",
        "open_recall": false
      },
      {
        "name": "Argon/Krypton & Krypton Laser Photocoagulation Sys",
        "url": "https://devicerts.com/devices/argon-krypton-and-krypton-laser-photocoagulation-sys-hqb",
        "model_reference": "K844197",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1984-12-24",
        "open_recall": false
      },
      {
        "name": "Nidek Model Nt-1000",
        "url": "https://devicerts.com/devices/nidek-model-nt-1000-hkx",
        "model_reference": "K913189",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1991-10-15",
        "open_recall": false
      },
      {
        "name": "Omron Ultrasonic Nebulizer Ne-U06",
        "url": "https://devicerts.com/devices/omron-ultrasonic-nebulizer-ne-u06-caf",
        "model_reference": "K875134",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1988-12-05",
        "open_recall": false
      },
      {
        "name": "Nidek Advanced Vision Information System (Navis)",
        "url": "https://devicerts.com/devices/nidek-advanced-vision-information-system-navis-nfj",
        "model_reference": "K013694",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2002-11-19",
        "open_recall": false
      },
      {
        "name": "Nidek Up-2000",
        "url": "https://devicerts.com/devices/nidek-up-2000-iyo",
        "model_reference": "K880065",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1988-03-15",
        "open_recall": false
      },
      {
        "name": "Nidek Cv-12000",
        "url": "https://devicerts.com/devices/nidek-cv-12000-hqc",
        "model_reference": "K924260",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1993-03-26",
        "open_recall": false
      },
      {
        "name": "Argon Laser Photocoagulator Sys Repeat Mode",
        "url": "https://devicerts.com/devices/argon-laser-photocoagulator-sys-repeat-mode-hqb",
        "model_reference": "K844198",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1984-12-24",
        "open_recall": false
      },
      {
        "name": "Ar-1600 Automatic Refractor",
        "url": "https://devicerts.com/devices/ar-1600-automatic-refractor-hko",
        "model_reference": "K861062",
        "device_class": "Class I",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1986-04-04",
        "open_recall": false
      },
      {
        "name": "Ar-1000 Automatic Refractor",
        "url": "https://devicerts.com/devices/ar-1000-automatic-refractor-hko",
        "model_reference": "K861066",
        "device_class": "Class I",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1986-04-04",
        "open_recall": false
      },
      {
        "name": "Nidek, Inc. Bio-Dc Laser Delivery System",
        "url": "https://devicerts.com/devices/nidek-inc-bio-dc-laser-delivery-system-gex",
        "model_reference": "K900165",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1990-03-22",
        "open_recall": false
      },
      {
        "name": "Nidek/Phaco Emulsification System Model Cv-8000",
        "url": "https://devicerts.com/devices/nidek-phaco-emulsification-system-model-cv-8000-hqc",
        "model_reference": "K901686",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1990-06-08",
        "open_recall": false
      },
      {
        "name": "Nidek Adc-8000 Laser System",
        "url": "https://devicerts.com/devices/nidek-adc-8000-laser-system-hqf",
        "model_reference": "K872846",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1987-10-15",
        "open_recall": false
      },
      {
        "name": "Nidek Ar-1200",
        "url": "https://devicerts.com/devices/nidek-ar-1200-hko",
        "model_reference": "K890559",
        "device_class": "Class I",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1989-02-27",
        "open_recall": false
      },
      {
        "name": "Nidek Model Yc-1200",
        "url": "https://devicerts.com/devices/nidek-model-yc-1200-lxs",
        "model_reference": "K893987",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1989-08-18",
        "open_recall": false
      },
      {
        "name": "Nidek Inc. Models Yc-2000 & 3000 Ophthalmic Lasers",
        "url": "https://devicerts.com/devices/nidek-inc-models-yc-2000-and-3000-ophthalmic-lasers-lxs",
        "model_reference": "K892204",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1989-06-22",
        "open_recall": false
      },
      {
        "name": "Nidek Us-3000",
        "url": "https://devicerts.com/devices/nidek-us-3000-iyo",
        "model_reference": "K882162",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1988-08-19",
        "open_recall": false
      },
      {
        "name": "Epi-Star Surgical Laser Syster",
        "url": "https://devicerts.com/devices/epi-star-surgical-laser-syster-gex",
        "model_reference": "K990119",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2000-07-27",
        "open_recall": false
      },
      {
        "name": "Nidek Model Adc-8000",
        "url": "https://devicerts.com/devices/nidek-model-adc-8000-gex",
        "model_reference": "K894709",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1989-10-04",
        "open_recall": false
      },
      {
        "name": "Nidek Model Akc-8000 Ophthalmic Laser Photocoagula",
        "url": "https://devicerts.com/devices/nidek-model-akc-8000-ophthalmic-laser-photocoagula-gex",
        "model_reference": "K900890",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1990-09-10",
        "open_recall": false
      },
      {
        "name": "Nidek Digital Keratometer",
        "url": "https://devicerts.com/devices/nidek-digital-keratometer-hql",
        "model_reference": "K842892",
        "device_class": "Class III",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1984-10-05",
        "open_recall": false
      },
      {
        "name": "Multi Color Laser Photocoagulator, Model Mc-300",
        "url": "https://devicerts.com/devices/multi-color-laser-photocoagulator-model-mc-300-gex",
        "model_reference": "K042785",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2004-12-14",
        "open_recall": false
      },
      {
        "name": "Nidek Km-1000 Surgical Keratometer",
        "url": "https://devicerts.com/devices/nidek-km-1000-surgical-keratometer-hlq",
        "model_reference": "K862137",
        "device_class": "Class I",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1986-07-23",
        "open_recall": false
      },
      {
        "name": "Ar-1600g Auto-Refractometer",
        "url": "https://devicerts.com/devices/ar-1600g-auto-refractometer-hko",
        "model_reference": "K902500",
        "device_class": "Class I",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1990-07-27",
        "open_recall": false
      },
      {
        "name": "Nidek Km-800 Auto Keratometer",
        "url": "https://devicerts.com/devices/nidek-km-800-auto-keratometer-hlq",
        "model_reference": "K861063",
        "device_class": "Class I",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1986-04-04",
        "open_recall": false
      },
      {
        "name": "Nidek Ac-2000 Laser System",
        "url": "https://devicerts.com/devices/nidek-ac-2000-laser-system-hqb",
        "model_reference": "K860011",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1986-02-07",
        "open_recall": false
      },
      {
        "name": "Nidek Multi Color Laser Photocoagulator, Model Mc-7000",
        "url": "https://devicerts.com/devices/nidek-multi-color-laser-photocoagulator-model-mc-7000-gex",
        "model_reference": "K974732",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1998-03-18",
        "open_recall": false
      },
      {
        "name": "Nidek Model Vst-4000",
        "url": "https://devicerts.com/devices/nidek-model-vst-4000-hqe",
        "model_reference": "K924353",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1993-03-29",
        "open_recall": false
      },
      {
        "name": "Monocular Direct Ophthalmoscope",
        "url": "https://devicerts.com/devices/monocular-direct-ophthalmoscope-hli",
        "model_reference": "K844971",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1985-02-15",
        "open_recall": false
      }
    ]
  },
  "certificates": [],
  "recalls": []
}