{
  "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": 11
    }
  },
  "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": "OMNILUX MEDICAL BLUE HEAD",
      "public_device_record_key": "e686dc0c-d15c-44a5-9f01-8b5c09b6b0dd",
      "has_serial_number": "true",
      "public_version_date": "2022-12-08",
      "sterilization": {
        "is_sterile": "false",
        "is_sterilization_prior_use": "false"
      },
      "is_direct_marking_exempt": "false",
      "public_version_number": "5",
      "labeler_duns_number": "969797406",
      "is_labeled_as_no_nrl": "false",
      "identifiers": [
        {
          "id": "B434EM1310",
          "type": "Primary",
          "issuing_agency": "HIBCC"
        }
      ],
      "is_single_use": "false",
      "is_otc": "false",
      "version_or_model_number": "EM1310",
      "has_manufacturing_date": "true",
      "brand_name": "OMNILUX",
      "is_combination_product": "false",
      "is_kit": "false",
      "product_codes": [
        {
          "code": "GEX",
          "name": "Powered Laser Surgical Instrument",
          "openfda": {
            "device_name": "Powered Laser Surgical Instrument",
            "medical_specialty_description": "General, Plastic Surgery",
            "regulation_number": "878.4810",
            "device_class": "2"
          }
        }
      ],
      "device_count_in_base_package": "1",
      "is_pm_exempt": "false",
      "has_lot_or_batch_number": "false",
      "company_name": "LOTUS GLOBAL GROUP, INC, THE",
      "public_version_status": "Update",
      "has_expiration_date": "false",
      "is_hct_p": "false",
      "gmdn_terms": [
        {
          "code": "60409",
          "name": "Musculoskeletal/physical therapy laser, professional",
          "definition": "An electrically-powered diode laser intended to provide non-surgical laser therapy [e.g., infrared phototherapy, low-level laser therapy (LLLT)] for localized treatment of musculoskeletal conditions (e.g., muscle/joint pain, sports injury), improvement of local blood circulation in the treated areas to facilitate healing, or for non-needle acupuncture. It typically consists of a control unit which may be mounted on a mobile trolley, a foot-switch, and a connected applicator/beam guide designed for intra-orifice (e.g., intravaginal) or transcutaneous delivery of visible red/infrared laser light energy/heat. It is intended to be operated exclusively by a healthcare professional.",
          "implantable": "false",
          "code_status": "Active"
        },
        {
          "code": "59822",
          "name": "Skin photodynamic therapy/phototherapy lamp",
          "definition": "A portable, mains electricity (AC-powered) lamp intended to emit low-level narrow-band (LLNB) red light (e.g., 600-650nm) and blue light (e.g., 415-440nm) either separately or simultaneously for photodynamic therapy (PDT) applications (with photosensitizing agent) to treat skin disorders such as actinic keratosis and non-melanoma skin cancer, and for phototherapy applications (through modification of skin metabolism) to treat skin complaints such as acne, rosacea and sun spots. It uses light-emitting diodes (LEDs) to produce a heatless light source which may be used for treatment at multiple anatomical sites. It is intended to be used by a healthcare professional in a clinical setting.",
          "implantable": "false",
          "code_status": "Active"
        }
      ],
      "publish_date": "2016-12-05"
    }
  ]
}