{
  "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": 105
    }
  },
  "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": "RESTYLANE LYFT with Lidocaine is a sterile, biodegradable, transparent gel of stabilized hyaluronic acid of non-animal origin with the additon of lidocaine hydrochloride  0.3%. It is indicated in patients over the age of 21 for implantation into the deep dermis to superficial subcutis for the correction of moderate to severe facial folds and wrinkles, such as nasolabial folds; for subcutaneous to supraperiosteal implantation for cheek augmentation and correction of age-related midface contour deficiencies; and for injection into the subcutaneous plane in the dorsal hand to correct volume deficit.",
      "public_device_record_key": "50d0505b-d5dd-4c14-b6ec-6849c2932cae",
      "has_serial_number": "false",
      "storage": [
        {
          "type": "Storage Environment Temperature",
          "high": {
            "unit": "Degrees Celsius",
            "value": "25"
          },
          "low": {
            "unit": "Degrees Celsius"
          }
        },
        {
          "type": "Storage Environment Temperature",
          "high": {
            "unit": "Degrees Fahrenheit",
            "value": "77"
          },
          "low": {
            "unit": "Degrees Fahrenheit"
          }
        },
        {
          "type": "Special Storage Condition, Specify",
          "special_conditions": "Do not expose to direct sunlight"
        },
        {
          "type": "Special Storage Condition, Specify",
          "special_conditions": "Refrigeration not required"
        },
        {
          "type": "Special Storage Condition, Specify",
          "special_conditions": "Do not freeze"
        }
      ],
      "public_version_date": "2025-07-08",
      "sterilization": {
        "is_sterile": "true",
        "is_sterilization_prior_use": "false"
      },
      "is_direct_marking_exempt": "false",
      "public_version_number": "1",
      "labeler_duns_number": "468910220",
      "is_labeled_as_no_nrl": "false",
      "identifiers": [
        {
          "id": "08437027710087",
          "type": "Primary",
          "issuing_agency": "GS1"
        }
      ],
      "is_single_use": "true",
      "is_otc": "false",
      "version_or_model_number": "Gel 1 mL Syringe",
      "has_manufacturing_date": "false",
      "brand_name": "RESTYLANE LYFT WITH LIDOCAINE",
      "is_combination_product": "true",
      "is_kit": "false",
      "product_codes": [
        {
          "code": "LMH",
          "name": "Implant, Dermal, For Aesthetic Use",
          "openfda": {
            "device_name": "Implant, Dermal, For Aesthetic Use",
            "medical_specialty_description": "Unknown",
            "regulation_number": "",
            "device_class": "3"
          }
        },
        {
          "code": "PKY",
          "name": "Implant, Dermal, For Aesthetic Use In The Hands",
          "openfda": {
            "device_name": "Implant, Dermal, For Aesthetic Use In The Hands",
            "medical_specialty_description": "Unknown",
            "regulation_number": "",
            "device_class": "3"
          }
        }
      ],
      "premarket_submissions": [
        {
          "submission_number": "P040024",
          "supplement_number": "000"
        }
      ],
      "device_count_in_base_package": "1",
      "is_pm_exempt": "false",
      "has_lot_or_batch_number": "true",
      "company_name": "SAIMA GLOBAL FARMA S.L.",
      "public_version_status": "New",
      "has_expiration_date": "true",
      "is_hct_p": "false",
      "gmdn_terms": [
        {
          "code": "47887",
          "name": "Dermal tissue reconstructive material, microbe-derived, anaesthetic",
          "definition": "A sterile, bioabsorbable, bacteria-derived substance intended to be injected into the dermis/hypodermis of the skin, lip submucosa, and/or for supraperiosteal administration to add volume by serving as a space-occupying supplement to the intercellular matrix of connective tissue (dermal filler), typically to correct cutaneous contour deformities (e.g., wrinkles, folds, scars) associated with aging, injury, or degenerative lesions; it includes a local anaesthetic agent (e.g., lidocaine). It typically includes bacterial hyaluronic acid (HA) as the principal constituent and is typically preloaded in a disposable syringe; disposable needle(s)/cannula(e) dedicated to injection may be included.",
          "implantable": "true",
          "code_status": "Active"
        }
      ],
      "publish_date": "2025-06-30"
    }
  ]
}