{
  "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": "2026-07-27",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 61
    }
  },
  "results": [
    {
      "pma_number": "P030008",
      "supplement_number": "S005",
      "applicant": "Alcon Laboratories, Inc.",
      "street_1": "6201 S. Fwy.",
      "street_2": "",
      "city": "Fort Worth",
      "state": "TX",
      "zip": "76134",
      "zip_ext": "",
      "generic_name": "Excimer laser system",
      "trade_name": "WAVELIGHT ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM",
      "product_code": "LZS",
      "advisory_committee": "OP",
      "advisory_committee_description": "Ophthalmic",
      "supplement_type": "Normal 180 Day Track",
      "supplement_reason": "Change Design/Components/Specifications/Material",
      "expedited_review_flag": "N",
      "date_received": "2006-12-19",
      "decision_date": "2007-04-09",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "APPROVAL FOR A CHANGE IN THE REPETITION RATE FROM 200 HZ TO 400 HZ.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM AND IS INDICATED FOR LASER ASSISTED IN SITU KERATOMILEUSIS (LASIK) FOR: 1) THE REDUCTION OR ELIMINATION OF NATURALLY OCCURRING MIXED ASTIGMATISM OF UP TO 6.00 DIOPTERS (D) AT THE SPECTACLE PLANE IN PATIENTS WHO ARE 21 YEARS OF AGE OR OLDER WITH DOCUMENTATION OF A STABLE MANIFEST REFRACTION DEFINED AS <=0.50 D OF PREOPERATIVE SPHERICAL EQUIVALENT SHIFT OVER ONE YEAR PRIOR TO SURGERY; AND 2) THE WAVEFRONT-GUIDED (WFG) REDUCTION OR ELIMINATION OF UP TO -7.00 DIOPTERS (D) OF SPHERICAL EQUIVALENT MYOPIA OR MYOPIA WITH ASTIGMATISM, WITH UP TO -7.00 D OF SPHERICAL COMPONENT AND UP TO 3.00 D OF ASTIGMATIC COMPONENT AT THE SPECTACLE PLANE IN PATIENTS WHO ARE 18 YEARS OF AGE OR OLDER WITH DOCUMENTATION OF A STABLE MANIFEST REFRACTION DEFINED AS <=0.50 D OF PREOPERATIVE SPHERICAL SHIFT OVER ONE YEAR PRIOR TO SURGERY.",
      "openfda": {
        "registration_number": [
          "3007606649",
          "3012236936",
          "9615030",
          "1920664",
          "9710340",
          "2936921",
          "3002807715",
          "3038356864",
          "8030392",
          "3003288808",
          "3006695864"
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        "fei_number": [
          "3012236936",
          "1920664",
          "3002483854",
          "2936921",
          "3002807715",
          "3038356864",
          "3003288808",
          "3003691824",
          "3001362763",
          "3006695864"
        ],
        "device_name": "Excimer Laser System",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}