{
  "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": 1
    }
  },
  "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 LED Light Therapy Mask adopts light emitting diodes (LED) in the red (660nm±10nm) ,blue (415nm±10nm),yellow (590nm±10nm) and infrared (850nm±10nm) spectrum to irradiate on the face to realize its therapeutic effect. The LED Light Therapy Mask adopts the form of a mask that contains LEDs on the inner surface of the main unit. A controller is connected to the main unit to control the device, such as turn on/off the device, switch mode (LED color), select energy level and start/pause light output. To use the device, user should place the mask over the face and use the controller to operate. The device will automatically turn off after each treatment. To prevent irradiation of LED lights to eyes during the treatment, LED Light Therapy Mask has incorporated protective eye-shield which blocks light energy from LEDs.",
      "public_device_record_key": "276ebf60-d2c3-4f07-9f91-611095e72227",
      "has_serial_number": "true",
      "public_version_date": "2025-08-21",
      "sterilization": {
        "is_sterile": "false",
        "is_sterilization_prior_use": "false"
      },
      "is_direct_marking_exempt": "false",
      "public_version_number": "1",
      "labeler_duns_number": "402713443",
      "is_labeled_as_no_nrl": "false",
      "identifiers": [
        {
          "id": "06976006415138",
          "type": "Primary",
          "issuing_agency": "GS1"
        }
      ],
      "is_single_use": "false",
      "is_otc": "true",
      "version_or_model_number": "BBL-FACEMASK",
      "has_manufacturing_date": "false",
      "brand_name": "N/A",
      "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": "K250830",
          "supplement_number": "000"
        }
      ],
      "device_count_in_base_package": "1",
      "is_pm_exempt": "false",
      "has_lot_or_batch_number": "false",
      "customer_contacts": [
        {
          "phone": "+8615219482246",
          "email": "sales2@sgrowled.com"
        }
      ],
      "company_name": "Shenzhen Sungrow LED Technology Co., LTD",
      "public_version_status": "New",
      "has_expiration_date": "true",
      "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": "2025-08-13"
    }
  ]
}