{
  "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": "2026-09-28",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
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  "results": [
    {
      "third_party_flag": "N",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Ineligible",
      "product_code": "QGM",
      "openfda": {
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      "review_panel": "SU",
      "medical_specialty": "SU",
      "device_name": "Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "General, Plastic Surgery",
      "device_class": "2",
      "definition": "This device uses focused ultrasound to mechanically ablate soft tissue. The device is not intended to thermally ablate tissue.",
      "regulation_number": "878.4405",
      "implant_flag": "N",
      "submission_type_id": "1"
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}