{
  "format": "devicerts.device.v1",
  "cite_as": "Vitra 2, Quantel Medical. deviCERTS medical device catalogue. https://devicerts.com/devices/vitra-2-gex (data as of 2026-11-15).",
  "source": {
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    "markdown_url": "https://devicerts.com/devices/vitra-2-gex.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
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      {
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        "url": "https://ec.europa.eu/tools/eudamed"
      }
    ],
    "registry_records_last_synced": "2026-10-22",
    "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/devices/vitra-2-gex",
    "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": "Vitra 2",
    "registry_name": "Vitra 2",
    "url": "https://devicerts.com/devices/vitra-2-gex",
    "manufacturer": {
      "name": "Quantel Medical",
      "url": "https://devicerts.com/manufacturers/quantel-medical",
      "country": null,
      "country_basis": null,
      "fda_registration_country": "France"
    },
    "status": {
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      "label": "Active",
      "detail": "European Union and United States"
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        "system": "US FDA"
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        "values": [
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        ]
      }
    ],
    "product_codes": [
      "GEX"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The Vitra 2 is a retinal photocoagulation laser designed for ophthalmic use. It delivers precise laser treatment to the retina, primarily for managing conditions such as diabetic retinopathy, age-related macular degeneration, and retinal vascular abnormalities. This device operates at a wavelength of 532 nm, enabling targeted photocoagulation with controlled energy delivery. Its classification aligns with ophthalmic laser systems used in surgical and therapeutic retinal interventions.\n\nThe Vitra 2 is supplied as a standalone system compatible with Haag-Streit and Zeiss slit lamps, facilitating integration into existing ophthalmic examination setups. It is intended for use in clinical environments, including outpatient clinics and hospital ophthalmology departments, where retinal procedures are performed. The device is not described as single-use or reusable in the specifications, though its sterility and maintenance protocols would follow standard clinical laser device guidelines. No explicit MRI safety information is provided, and its regulatory authorisations include FDA 510(k) clearance under the General, Plastic Surgery advisory committee and compliance with the MDD (Medical Device Directive).",
      "ai_generated": true,
      "generated_on": "2026-09-18",
      "note": "Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record."
    },
    "noindex": false
  },
  "authorizations": [
    {
      "registry": "510(k)",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K191962",
      "number_label": null,
      "device_udi_di": null,
      "date": "2019-12-05",
      "date_kind": "decision",
      "decision_code": "SESE",
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    },
    {
      "registry": "EUDAMED",
      "region": "European Union",
      "type": "CE/MDD",
      "number": null,
      "number_label": null,
      "device_udi_di": null,
      "date": null,
      "date_kind": null,
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      "status": "Active",
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      "derived_from_gudid": false
    }
  ],
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  "certificates": [],
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  "eu_market_availability": null,
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    {
      "group": "Classification",
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        {
          "label": "Device class",
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            {
              "value": "Class II",
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            }
          ]
        },
        {
          "label": "Regulation",
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            {
              "value": "21 CFR Part 878.4810",
              "registries": [
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              ]
            }
          ]
        },
        {
          "label": "Advisory committee",
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            {
              "value": "General, Plastic Surgery",
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}