{
  "format": "devicerts.manufacturer.v1",
  "cite_as": "Neolight LLC. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/neolight-llc (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/manufacturers/neolight-llc",
    "json_url": "https://devicerts.com/manufacturers/neolight-llc.json",
    "markdown_url": "https://devicerts.com/manufacturers/neolight-llc.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA GUDID",
        "url": "https://accessgudid.nlm.nih.gov/"
      },
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      },
      {
        "registry": "EUDAMED",
        "url": "https://ec.europa.eu/tools/eudamed"
      }
    ],
    "eudamed_record_synced": null,
    "fda_recalls_as_of": "2026-11-01",
    "registry_facts_computed": "2026-11-15",
    "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/neolight-llc",
    "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": "Neolight LLC",
    "url": "https://devicerts.com/manufacturers/neolight-llc",
    "registered_as": null,
    "abbreviated_name": null,
    "also_registered_as": [],
    "country": "United States",
    "country_basis": "FDA applicant, unverified",
    "eudamed_status": null,
    "verified": false,
    "roles": [
      "Manufacturer"
    ],
    "registrations": [],
    "identifiers": [
      {
        "label": "DUNS",
        "value": "074301687"
      }
    ],
    "summary": "Neolight LLC is a medical device manufacturer, with 27 devices listed in FDA GUDID, FDA 510(k) and EUDAMED (FDA Class II and I) as of 15 Nov 2026.",
    "noindex": false
  },
  "counts": {
    "devices": 27,
    "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 GUDID",
        "devices": 25
      },
      {
        "registry": "FDA 510(k)",
        "devices": 2
      },
      {
        "registry": "EUDAMED",
        "devices": 1
      }
    ],
    "device_classes": [
      {
        "class": "FDA Class II",
        "devices": 24
      },
      {
        "class": "FDA Class I",
        "devices": 3
      }
    ],
    "top_emdn_categories": []
  },
  "related": {
    "site_of": null,
    "part_of": null,
    "sites": [],
    "authorised_representatives": []
  },
  "devices": {
    "shown": 27,
    "total": 27,
    "all_devices_url": "https://devicerts.com/manufacturers/neolight-llc",
    "items": [
      {
        "name": "NeoLight Bassinet Basket Loaner 300064",
        "url": "https://devicerts.com/devices/neolight-bassinet-basket-loaner-neo-bask-lnr",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Neolight PCI 40-1004",
        "url": "https://devicerts.com/devices/neolight-pci-40-1004",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Neolight PCI 40-1100FA",
        "url": "https://devicerts.com/devices/neolight-pci-40-1100fa",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Neolight PCI 40-1002",
        "url": "https://devicerts.com/devices/neolight-pci-40-1002",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "GelMat NL-SK-2-212",
        "url": "https://devicerts.com/devices/gelmat-nl-sk-2-212",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Light Module NL-SK-3",
        "url": "https://devicerts.com/devices/light-module-nl-sk-3",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Posey Eye Protection NL-EP-01S-PREMIE",
        "url": "https://devicerts.com/devices/posey-eye-protection-nl-ep-01s-premie",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Neolight PCI 40-1005",
        "url": "https://devicerts.com/devices/neolight-pci-40-1005",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "CloudCover NL-SK-5S",
        "url": "https://devicerts.com/devices/cloudcover-nl-sk-5s",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Neolight PCI 40-2100FA",
        "url": "https://devicerts.com/devices/neolight-pci-40-2100fa",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Neolight PCI 40-1017",
        "url": "https://devicerts.com/devices/neolight-pci-40-1017",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Neolight PCI 30-1000",
        "url": "https://devicerts.com/devices/neolight-pci-30-1000",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Neolight PCI 40-1100",
        "url": "https://devicerts.com/devices/neolight-pci-40-1100",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Neolight PCI 40-1003",
        "url": "https://devicerts.com/devices/neolight-pci-40-1003",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Cloud Swaddle NL-SK-5",
        "url": "https://devicerts.com/devices/cloud-swaddle-nl-sk-5",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Neolight PCI 40-2100",
        "url": "https://devicerts.com/devices/neolight-pci-40-2100",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Posey Eye Protection NL-EP-01S-NEWBORN",
        "url": "https://devicerts.com/devices/posey-eye-protection-nl-ep-01s-newborn",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Skylife Controller NL-SK-1",
        "url": "https://devicerts.com/devices/skylife-controller-nl-sk-1",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "GelMat Consumable NL-SK-2-212",
        "url": "https://devicerts.com/devices/gelmat-consumable-nl-sk-6",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "NeoLight Bassinet Basket 300063",
        "url": "https://devicerts.com/devices/neolight-bassinet-basket-neo-bask",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Skylife Lightbed NL-SK-2",
        "url": "https://devicerts.com/devices/skylife-lightbed-nl-sk-2",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Neolight PCI 40-1030",
        "url": "https://devicerts.com/devices/neolight-pci-40-1030",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Skylife System NL-SK",
        "url": "https://devicerts.com/devices/skylife-system-nl-sk",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "CloudCover Plus NL-SK-8S",
        "url": "https://devicerts.com/devices/cloudcover-plus-nl-sk-8s",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Posey Eye Protection NL-EP-01S-MICRO",
        "url": "https://devicerts.com/devices/posey-eye-protection-nl-ep-01s-micro",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Phoenix ICON, Phoenix ICON GO",
        "url": "https://devicerts.com/devices/phoenix-icon-phoenix-icon-go-hki",
        "model_reference": "K223575",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2023-09-06",
        "open_recall": false
      },
      {
        "name": "Skylife",
        "url": "https://devicerts.com/devices/skylife-lbi",
        "model_reference": "K170585",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2017-10-27",
        "open_recall": false
      }
    ]
  },
  "certificates": [],
  "recalls": []
}