{
  "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": 12
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  },
  "results": [
    {
      "pma_number": "P090012",
      "supplement_number": "S006",
      "applicant": "Strata Skin Sciences, Inc.",
      "street_1": "100 Lakeside Dr. Suite 100",
      "street_2": "",
      "city": "Horsham",
      "state": "PA",
      "zip": "19044",
      "zip_ext": "",
      "generic_name": "Optical diagnostic device for melanoma detection",
      "trade_name": "MELAFIND",
      "product_code": "OYD",
      "advisory_committee": "SU",
      "advisory_committee_description": "General, Plastic Surgery",
      "supplement_type": "135 Review Track For 30-Day Notice",
      "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
      "expedited_review_flag": "N",
      "date_received": "2014-04-29",
      "decision_date": "2016-01-12",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "APPROVAL FOR THE FOLLOWING CHANGES:1) CHANGES TO THE TOLERANCES IN THE COMPUTER MOUNT AND SWITCH BRACKET;2) RELOCATION OF MOUNTING HOLES ON THE COMPLEMENTARY METAL OXIDE SEMICONDUCTOR (CMOS) PRINTED CIRCUIT BOARD (PCB); 3) OPTIMIZATION OF POWER SUPPLY CAPACITORS AND ADDITION OF RESISTOR VALUES TO TEST SET; AND; 3) CHANGES TO COMPUTER LED INDICATOR AND ASSOCIATED WIRING.",
      "openfda": {
        "device_name": "Optical Diagnostic Device For Melanoma Detection",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.1820",
        "device_class": "2"
      }
    }
  ]
}