{
  "format": "devicerts.device.v1",
  "cite_as": "Integre Pro Scan Red-Green LP6RG, Ellex Medical Pty Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/integre-pro-scan-red-green-lp6rg (data as of 2026-11-14).",
  "source": {
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    "json_url": "https://devicerts.com/devices/integre-pro-scan-red-green-lp6rg.json",
    "markdown_url": "https://devicerts.com/devices/integre-pro-scan-red-green-lp6rg.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA GUDID (AccessGUDID)",
        "url": "https://accessgudid.nlm.nih.gov/"
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      {
        "registry": "FDA recalls",
        "url": "https://open.fda.gov/apis/device/recall/"
      }
    ],
    "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/integre-pro-scan-red-green-lp6rg",
    "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": "Integre Pro Scan Red-Green LP6RG",
    "registry_name": "Integre Pro Scan Red-Green LP6RG",
    "url": "https://devicerts.com/devices/integre-pro-scan-red-green-lp6rg",
    "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": {
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      "label": "Active",
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    },
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        "class": "Class II",
        "system": "US FDA"
      }
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          {
            "value": "09342395000144",
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            ]
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      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K142398",
            "registries": [
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    ],
    "product_codes": [
      "HQF"
    ],
    "emdn": [],
    "gmdn": [
      {
        "code": "62197",
        "term": "Ophthalmic solid-state laser system"
      }
    ],
    "description": null,
    "noindex": true
  },
  "authorizations": [
    {
      "registry": "GUDID",
      "region": "United States",
      "type": "GUDID listing",
      "number": "09342395000144",
      "number_label": "UDI-DI",
      "device_udi_di": null,
      "date": "2016-03-02",
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      "decision_code": null,
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      "status": "Listed",
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      "date": "2015-07-14",
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    }
  ],
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      "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",
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        {
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