{
  "format": "devicerts.device.v1",
  "cite_as": "VIKINI Diode Laser System, Ilooda.co., Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/vikini-diode-laser-system-gex (data as of 2026-11-14).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/vikini-diode-laser-system-gex",
    "json_url": "https://devicerts.com/devices/vikini-diode-laser-system-gex.json",
    "markdown_url": "https://devicerts.com/devices/vikini-diode-laser-system-gex.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": "2026-11-14",
    "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/vikini-diode-laser-system-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": "VIKINI Diode Laser System",
    "registry_name": "VIKINI Diode Laser System",
    "url": "https://devicerts.com/devices/vikini-diode-laser-system-gex",
    "manufacturer": {
      "name": "Ilooda.co., Ltd",
      "url": "https://devicerts.com/manufacturers/ilooda-co-ltd",
      "country": "South Korea",
      "country_basis": "FDA 510(k) applicant",
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "United States"
    },
    "classification": [
      {
        "class": "Class II",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K151232",
            "registries": [
              "FDA 510(k)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "GEX"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The Vikini Diode Laser System is a diode laser device classified under product code GEX, designed for hair removal, permanent hair reduction, and treatment of benign vascular and pigmented lesions. It operates by delivering controlled laser energy to target tissues, enabling precise and effective cosmetic and dermatological interventions in clinical settings.\n\nThis system is intended for use by trained healthcare professionals in regulated environments and has received FDA 510(k) clearance under the Traditional review pathway. It is supplied as a reusable medical device under the classification of Class 2, adhering to regulatory standards outlined in 21 CFR 878.4810. The device is manufactured by Ilooda Co., Ltd., based in South Korea.",
      "ai_generated": true,
      "generated_on": "2026-09-19",
      "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": "K151232",
      "number_label": null,
      "device_udi_di": null,
      "date": "2015-08-06",
      "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": "K151232",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA product code",
          "values": [
            {
              "value": "GEX",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        }
      ]
    },
    {
      "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",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        }
      ]
    }
  ]
}