{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-10-19",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 7
    }
  },
  "results": [
    {
      "pma_number": "P150046",
      "supplement_number": "",
      "applicant": "Scibase AB",
      "street_1": "Kammakargatan 22",
      "street_2": "",
      "city": "Stockholm",
      "state": "",
      "zip": "SE-1140",
      "zip_ext": "",
      "generic_name": "Electrical Impedance Spectrometer",
      "trade_name": "NEVISENSE",
      "product_code": "ONV",
      "advisory_committee": "SU",
      "advisory_committee_description": "General, Plastic Surgery",
      "supplement_type": "",
      "supplement_reason": "",
      "expedited_review_flag": "N",
      "date_received": "2015-12-07",
      "decision_date": "2017-06-28",
      "docket_number": "17M-3982",
      "fed_reg_notice_date": "2017-06-30",
      "decision_code": "APRL",
      "ao_statement": "Approval for the Nevisense.  This device is indicated for use on cutaneous lesions with one or more clinical or historical characteristics of melanoma, when a dermatologist chooses to obtain additional information when considering biopsy. Nevisense should not be used on clinically obvious melanoma. The Nevisense result is one element of the overall clinical assessment. The output of Nevisense should be used in combination with clinical and historical signs of melanoma to obtain additional information prior to a decision to biopsy. Nevisense is indicated only for use on: primary skin lesions with a diameter between 2 mm and 20 mm; lesions that are accessible by the Nevisense probe; lesions where the skin is intact (i.e., non-ulcerated or non-bleeding lesions); lesions that do not contain a scar or fibrosis consistent with previous trauma; lesions not located in areas of psoriasis, eczema, acute sunburn, or similar skin conditions; lesions not in hair-covered areas; lesions which do not contain foreign matter; lesions not on special anatomic sites (i.e., not for use on acral skin, genitalia, eyes, mucosal areas).",
      "openfda": {
        "registration_number": [
          "3002808022",
          "3008285458"
        ],
        "fei_number": [
          "3002808022",
          "3008285458"
        ],
        "device_name": "Electrical Impedance Spectrometer",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.1820",
        "device_class": "2"
      }
    }
  ]
}