{
  "format": "devicerts.device.v1",
  "cite_as": "Ellex 6340800, Ellex Medical Pty Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/ellex-6340800 (data as of 2026-11-14).",
  "source": {
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    "markdown_url": "https://devicerts.com/devices/ellex-6340800.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
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        "url": "https://accessgudid.nlm.nih.gov/"
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      {
        "registry": "FDA recalls",
        "url": "https://open.fda.gov/apis/device/recall/"
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    ],
    "registry_records_last_synced": "2026-10-23",
    "status_as_of": "2026-11-14",
    "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/devices/ellex-6340800",
    "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."
  },
  "device": {
    "name": "Ellex 6340800",
    "registry_name": "Ellex 6340800",
    "url": "https://devicerts.com/devices/ellex-6340800",
    "manufacturer": {
      "name": "Ellex Medical Pty Ltd",
      "url": "https://devicerts.com/manufacturers/ellex-medical-pty-ltd",
      "country": "Australia",
      "country_basis": null,
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "United States"
    },
    "classification": [
      {
        "class": "Class II",
        "system": "US FDA"
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        "values": [
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            "value": "09342395000861",
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            "value": "K081565",
            "registries": [
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          },
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        ]
      }
    ],
    "product_codes": [
      "HQF"
    ],
    "emdn": [],
    "gmdn": [
      {
        "code": "32729",
        "term": "Indirect binocular laser ophthalmoscope"
      }
    ],
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    "noindex": true
  },
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    {
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      "type": "GUDID listing",
      "number": "09342395000861",
      "number_label": "UDI-DI",
      "device_udi_di": null,
      "date": "2016-09-24",
      "date_kind": "listed",
      "decision_code": null,
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      "withdrawn": null,
      "status": "Listed",
      "status_note": "GUDID: in commercial distribution",
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      "type": "FDA 510(k)",
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      "date": "2015-07-14",
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      "status": "Active",
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    }
  ],
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      "number": "Z-1971-2023",
      "classification": "Class II",
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      "initiated": "2023-03-16",
      "reason": "When using a Laser-Indirect-Ophthalmoscope (LIO) as the delivery device, a scattered laser beam inside the laser cavity system may unintentionally exit through the Slit Lamp output port (SDS) and get emitted from the Objective Lens when the laser is fired.",
      "applies": "this device",
      "via": "K081565"
    }
  ],
  "eu_market_availability": null,
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