{
  "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": 2
    }
  },
  "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": "The Shark CryoGlow Mask is intended for the treatment of mild to moderate inflammatory acne and to treat fine lines and wrinkles.",
      "public_device_record_key": "19c3c999-1551-478a-b93d-5b1edd1c576c",
      "has_serial_number": "true",
      "public_version_date": "2026-06-10",
      "sterilization": {
        "is_sterile": "false",
        "is_sterilization_prior_use": "false"
      },
      "is_direct_marking_exempt": "false",
      "public_version_number": "1",
      "labeler_duns_number": "144444333",
      "is_labeled_as_no_nrl": "false",
      "identifiers": [
        {
          "id": "10622356642801",
          "type": "Primary",
          "issuing_agency": "GS1"
        }
      ],
      "is_single_use": "false",
      "is_otc": "true",
      "version_or_model_number": "FW312",
      "has_manufacturing_date": "false",
      "brand_name": "Shark CryoGlow",
      "is_combination_product": "false",
      "is_kit": "false",
      "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"
          }
        },
        {
          "code": "OLP",
          "name": "Over-The-Counter Powered Light Based Laser For Acne",
          "openfda": {
            "device_name": "Over-The-Counter Powered Light Based Laser For Acne",
            "medical_specialty_description": "General, Plastic Surgery",
            "regulation_number": "878.4810",
            "device_class": "2"
          }
        }
      ],
      "premarket_submissions": [
        {
          "submission_number": "K242796",
          "supplement_number": "000"
        }
      ],
      "device_count_in_base_package": "1",
      "is_pm_exempt": "false",
      "has_lot_or_batch_number": "false",
      "company_name": "SharkNinja Operating LLC",
      "public_version_status": "New",
      "has_expiration_date": "false",
      "is_hct_p": "false",
      "gmdn_terms": [
        {
          "code": "62116",
          "name": "Red/blue light phototherapy unit",
          "definition": "A portable electrically-powered device intended to emit both red and blue light for the treatment of a facial skin condition (e.g., acne, hyperpigmentation) by the patient in the home. It includes integral lights with a controller/controlling interface (to pair with an off-the-shelf computer/smartphone), and may be available in a variety of forms (e.g., a face-worn light mask with controller, hand-held light unit). It is not intended for use with a photosensitizing agent. This is a single-patient, reusable device.",
          "implantable": "false",
          "code_status": "Active"
        }
      ],
      "publish_date": "2026-06-02"
    }
  ]
}