{
  "format": "devicerts.device.v1",
  "cite_as": "AdvaTx, Advalight Aps. deviCERTS medical device catalogue. https://devicerts.com/devices/advatx-gex-k250189 (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/advatx-gex-k250189",
    "json_url": "https://devicerts.com/devices/advatx-gex-k250189.json",
    "markdown_url": "https://devicerts.com/devices/advatx-gex-k250189.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      }
    ],
    "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/advatx-gex-k250189",
    "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": "AdvaTx",
    "registry_name": "AdvaTx",
    "url": "https://devicerts.com/devices/advatx-gex-k250189",
    "manufacturer": {
      "name": "Advalight Aps",
      "url": "https://devicerts.com/manufacturers/advalight-aps",
      "country": null,
      "country_basis": null,
      "fda_registration_country": "Denmark"
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "United States"
    },
    "classification": [
      {
        "class": "Class II",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K250189",
            "registries": [
              "FDA 510(k)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "GEX"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "AdvaTx is a dual‑wavelength laser operating at 589 nm and 1319 nm, designed for dermatological and aesthetic procedures. The system delivers two distinct wavelengths to address a range of skin conditions and treatment goals.\n\nThe device is FDA‑510(k) cleared (K250189) and marketed by Advalight Aps, located in Bellerup, Denmark. It is supplied under product code GEX and is regulated as a traditional clearance, with no consumable components noted in the provided data.",
      "ai_generated": true,
      "generated_on": "2026-09-28",
      "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": "K250189",
      "number_label": null,
      "device_udi_di": null,
      "date": "2025-04-01",
      "date_kind": "decision",
      "decision_code": "SESE",
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
  "recalls": [],
  "eu_market_availability": null,
  "properties": [
    {
      "group": "Identifiers",
      "fields": [
        {
          "label": "510(k) Number",
          "values": [
            {
              "value": "K250189",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA product code",
          "values": [
            {
              "value": "GEX",
              "registries": [
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              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Classification",
      "fields": [
        {
          "label": "Device class",
          "values": [
            {
              "value": "Class II",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Regulation",
          "values": [
            {
              "value": "21 CFR Part 878.4810",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Advisory committee",
          "values": [
            {
              "value": "General, Plastic Surgery",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA decision",
          "values": [
            {
              "value": "SESE",
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            }
          ]
        }
      ]
    }
  ]
}