{
  "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": "2026-07-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Eligible",
      "product_code": "OAN",
      "openfda": {
        "k_number": [
          "K063098",
          "K082950",
          "K211376",
          "K011350",
          "K082945",
          "K072566",
          "K142141",
          "K244056",
          "K203098",
          "K021918",
          "K180109",
          "K124023",
          "K014012",
          "K090587",
          "K240466",
          "K133250",
          "K151979",
          "K021207",
          "K081994",
          "K081787",
          "K151147",
          "K161138",
          "K072862"
        ],
        "registration_number": [
          "1215709",
          "3015259854",
          "2032381",
          "1831680",
          "1000239400",
          "1058152",
          "1000560772",
          "1000246715",
          "1721652",
          "3003895329",
          "2030829",
          "3038871395",
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        "fei_number": [
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          "1721652",
          "1000560772",
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          "3003895329",
          "3038871395",
          "3042028951",
          "3003355324"
        ]
      },
      "review_panel": "NE",
      "medical_specialty": "NE",
      "device_name": "Orthosis, Cranial, Laser Scan",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Neurology",
      "device_class": "2",
      "definition": "A cranial orthosis is a device that is intended for medical purposes to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape.  A laser scanning accessory may be used to create a scan of the infant's head.  Indicated for infants from 3 to 18 months of age, with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.",
      "regulation_number": "882.5970",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}