{
  "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": "2026-10-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 23
    }
  },
  "results": [
    {
      "has_donation_id_number": "false",
      "mri_safety": "Labeling does not contain MRI Safety Information",
      "record_status": "Published",
      "is_labeled_as_nrl": "false",
      "is_rx": "true",
      "commercial_distribution_status": "In Commercial Distribution",
      "device_description": "THERMAGE FLX SKIN MARKING GRID (0.25 CM2)",
      "public_device_record_key": "3c939800-a21a-40aa-ba70-cb65bf2dba16",
      "has_serial_number": "false",
      "public_version_date": "2018-11-05",
      "sterilization": {
        "is_sterile": "false",
        "is_sterilization_prior_use": "false"
      },
      "is_direct_marking_exempt": "false",
      "public_version_number": "4",
      "labeler_duns_number": "079999584",
      "is_labeled_as_no_nrl": "false",
      "identifiers": [
        {
          "id": "00816995021292",
          "type": "Primary",
          "issuing_agency": "GS1"
        }
      ],
      "is_single_use": "true",
      "is_otc": "false",
      "version_or_model_number": "SM-0.25",
      "has_manufacturing_date": "true",
      "brand_name": "THERMAGE FLX",
      "is_combination_product": "false",
      "is_kit": "false",
      "product_codes": [
        {
          "code": "ISA",
          "name": "Massager, Therapeutic, Electric",
          "openfda": {
            "device_name": "Massager, Therapeutic, Electric",
            "medical_specialty_description": "Physical Medicine",
            "regulation_number": "890.5660",
            "device_class": "1"
          }
        },
        {
          "code": "GEI",
          "name": "Electrosurgical, Cutting & Coagulation & Accessories",
          "openfda": {
            "device_name": "Electrosurgical, Cutting & Coagulation & Accessories",
            "medical_specialty_description": "General, Plastic Surgery",
            "regulation_number": "878.4400",
            "device_class": "2"
          }
        }
      ],
      "device_count_in_base_package": "1",
      "is_pm_exempt": "false",
      "has_lot_or_batch_number": "true",
      "catalog_number": "SM-0.25",
      "company_name": "SOLTA MEDICAL",
      "public_version_status": "Update",
      "has_expiration_date": "false",
      "is_hct_p": "false",
      "gmdn_terms": [
        {
          "code": "62057",
          "name": "Skin marking transfer paper",
          "definition": "A non-sterile, noninvasive device intended to transfer a grid of ink dots onto the skin surface to assist a clinical procedure, such as accurate subcutaneous injection spacing. It is a non-latex transfer paper designed to be applied to the skin and then peeled away to leave the ink dots, which are subsequently removed from the skin (e.g., with alcohol) after the procedure. This is a single-use device.",
          "implantable": "false",
          "code_status": "Active"
        }
      ],
      "publish_date": "2017-11-08"
    }
  ]
}