{
  "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": "2026-06-01",
    "results": {
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  "results": [
    {
      "third_party_flag": "N",
      "city": "Beverly",
      "advisory_committee_description": "Obstetrics/Gynecology",
      "address_1": "100 Cummings Center-Suite 465e",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "MRX",
      "openfda": {
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          "3009107689",
          "3004871219",
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        "device_name": "System, Assisted Reproduction Laser",
        "medical_specialty_description": "Obstetrics/Gynecology",
        "regulation_number": "884.6200",
        "device_class": "2"
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      "zip_code": "01915",
      "applicant": "Hamilton Thorne, Inc.",
      "decision_date": "2012-04-24",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "HANILTON THORNE INFRARED LASER OPTICAL SYSTEM-ZILOS-TK  HAMILTON THORNE INFRARED LASER OPTICAL SYSTEM-LYKOS",
      "advisory_committee": "OB",
      "contact": "DIARMAID H DOUGLAS-HAMILTON",
      "expedited_review_flag": "",
      "k_number": "K120055",
      "state": "MA",
      "date_received": "2012-01-09",
      "review_advisory_committee": "OB",
      "postal_code": "01915",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
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}