{
  "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": "2026-09-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 7
    }
  },
  "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": "false",
      "commercial_distribution_status": "In Commercial Distribution",
      "device_description": "V2 facemask- faceLITE USA Branded (Refine USA)",
      "public_device_record_key": "70f55561-8141-4544-9d50-1ef0714c63d8",
      "has_serial_number": "true",
      "storage": [
        {
          "type": "Storage Environment Temperature",
          "high": {
            "unit": "Degrees Celsius",
            "value": "55"
          },
          "low": {
            "unit": "Degrees Celsius",
            "value": "-5"
          }
        },
        {
          "type": "Storage Environment Humidity",
          "high": {
            "unit": "Percent (%) Relative Humidity",
            "value": "85"
          },
          "low": {
            "unit": "Percent (%) Relative Humidity",
            "value": "20"
          }
        }
      ],
      "public_version_date": "2021-05-13",
      "sterilization": {
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        "is_sterilization_prior_use": "false"
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      "is_direct_marking_exempt": "false",
      "public_version_number": "1",
      "labeler_duns_number": "223616320",
      "is_labeled_as_no_nrl": "false",
      "identifiers": [
        {
          "id": "05060534510166",
          "type": "Primary",
          "issuing_agency": "GS1"
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      "is_otc": "true",
      "version_or_model_number": "TN19G",
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      "brand_name": "faceLITE USA",
      "is_combination_product": "false",
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      "product_codes": [
        {
          "code": "OHS",
          "name": "Light Based Over The Counter Wrinkle Reduction",
          "openfda": {
            "device_name": "Light Based Over The Counter Wrinkle Reduction",
            "medical_specialty_description": "General, Plastic Surgery",
            "regulation_number": "878.4810",
            "device_class": "2"
          }
        }
      ],
      "premarket_submissions": [
        {
          "submission_number": "K191629",
          "supplement_number": "000"
        }
      ],
      "device_count_in_base_package": "1",
      "is_pm_exempt": "false",
      "has_lot_or_batch_number": "true",
      "catalog_number": "111B",
      "company_name": "I-SMART DEVELOPMENTS LIMITED",
      "public_version_status": "New",
      "has_expiration_date": "false",
      "is_hct_p": "false",
      "gmdn_terms": [
        {
          "code": "47704",
          "name": "Cosmetic red-light phototherapy system, home-use",
          "definition": "An assembly of mains electricity (AC-powered) devices designed to emit low-level broad-band (LLBB) red light in the visible and invisible spectra together with heat [light and heat energy (LHE)] for the cosmetic treatment of dermatological conditions in the home. It typically consists of an energy generator and an attached applicator to apply the energy to the skin. It is designed to be operated by the patient typically for self body hair removal, skin rejuvenation, vascular and pigmented lesion removal, wrinkle reduction, collagen renewal, acne clearance, and/or mild to moderate psoriasis care.",
          "implantable": "false",
          "code_status": "Active"
        }
      ],
      "publish_date": "2021-05-05"
    }
  ]
}