{
  "format": "devicerts.device.v1",
  "cite_as": "Potenza, Jeisys Medical Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/potenza-16 (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/potenza-16",
    "json_url": "https://devicerts.com/devices/potenza-16.json",
    "markdown_url": "https://devicerts.com/devices/potenza-16.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "EUDAMED",
        "url": "https://ec.europa.eu/tools/eudamed"
      },
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      }
    ],
    "registry_records_last_synced": "2026-10-24",
    "status_as_of": "2026-11-15",
    "license": "CC BY 4.0",
    "license_url": "https://creativecommons.org/licenses/by/4.0/",
    "license_scope": "The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.",
    "attribution": "DevicErts, https://devicerts.com/devices/potenza-16",
    "disclaimer": "Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails."
  },
  "device": {
    "name": "Potenza",
    "registry_name": "POTENZA",
    "url": "https://devicerts.com/devices/potenza-16",
    "manufacturer": {
      "name": "Jeisys Medical Inc.",
      "url": "https://devicerts.com/manufacturers/jeisys-medical-inc",
      "country": "South Korea",
      "country_basis": null,
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "European Union and United States"
    },
    "classification": [
      {
        "class": "Class IIb",
        "system": "EU MDD"
      }
    ],
    "identifiers": [
      {
        "label": "Primary DI / UDI-DI",
        "values": [
          {
            "value": "08800020101785",
            "registries": [
              "EUDAMED"
            ]
          }
        ]
      },
      {
        "label": "Basic UDI-DI",
        "values": [
          {
            "value": "B-08800020101785",
            "registries": [
              "EUDAMED"
            ]
          }
        ]
      }
    ],
    "product_codes": [],
    "emdn": [
      {
        "code": "Z12010902",
        "term": "ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE"
      }
    ],
    "gmdn": [],
    "description": {
      "text": "The Potenza is a radiofrequency (RF) microneedling device classified under nomenclature code Z12010902, designed for non-invasive skin rejuvenation. It delivers controlled RF energy through microneedles to stimulate collagen production, improve skin texture, and address mild to moderate skin laxity or scarring. The device operates without implantable components, medicinal administration, or animal-derived materials, adhering to Class IIb regulatory standards.\n\nThis single-use device is non-sterile and intended for professional use in clinical or aesthetic settings. It is not reusable or reprocessed and requires no special MRI safety considerations. Supplied as a standalone unit with a reference code of 16, it is authorized under FDA 510K and MDD directives. Storage and handling follow standard medical device protocols, with compliance ensured through a Basic UDI (B-08800020101785) and regulatory oversight by Emergo Europe B.V.",
      "ai_generated": true,
      "generated_on": "2026-09-18",
      "note": "Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record."
    },
    "noindex": false
  },
  "authorizations": [
    {
      "registry": "510(k)",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K231216",
      "number_label": null,
      "device_udi_di": null,
      "date": "2024-12-10",
      "date_kind": "issued",
      "decision_code": null,
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    },
    {
      "registry": "EUDAMED",
      "region": "European Union",
      "type": "CE/MDD",
      "number": "B-08800020101785",
      "number_label": "Basic UDI-DI",
      "device_udi_di": "08800020101785",
      "date": "2024-11-22",
      "date_kind": "registered",
      "decision_code": null,
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    },
    {
      "registry": "510(k)",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K231287",
      "number_label": null,
      "device_udi_di": null,
      "date": "2024-11-05",
      "date_kind": "issued",
      "decision_code": null,
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    },
    {
      "registry": "510(k)",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K201685",
      "number_label": null,
      "device_udi_di": null,
      "date": "2021-01-19",
      "date_kind": "issued",
      "decision_code": null,
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
  "recalls": [],
  "eu_market_availability": null,
  "properties": [
    {
      "group": "Identity",
      "fields": [
        {
          "label": "Model / reference",
          "values": [
            {
              "value": "POTENZA",
              "registries": [
                "EUDAMED"
              ]
            },
            {
              "value": "16",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Identifiers",
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        {
          "label": "Primary DI / UDI-DI",
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            {
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            }
          ]
        },
        {
          "label": "Basic UDI-DI",
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            {
              "value": "B-08800020101785",
              "registries": [
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              ]
            }
          ]
        },
        {
          "label": "EMDN code",
          "values": [
            {
              "value": "Z12010902",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Classification",
      "fields": [
        {
          "label": "Device class",
          "values": [
            {
              "value": "Class IIb",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "System or procedure pack",
          "values": [
            {
              "value": "System which is a device in itself",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "EU registration type",
          "values": [
            {
              "value": "Legacy device (under a directive)",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "EU market of registration",
          "values": [
            {
              "value": "Netherlands",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Properties",
      "fields": [
        {
          "label": "Supplied sterile",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Sterilise before use",
          "values": [
            {
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              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Implantable",
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            {
              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Reusable",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Contains latex",
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            {
              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Reprocessed single-use device",
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            {
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              "registries": [
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            }
          ]
        },
        {
          "label": "Incorporates a substance derived from human blood or plasma",
          "values": [
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              "registries": [
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        },
        {
          "label": "Contains human tissues or cells",
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            }
          ]
        },
        {
          "label": "Contains animal tissues or cells",
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            {
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              "registries": [
                "EUDAMED"
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            }
          ]
        },
        {
          "label": "Administering medicine",
          "values": [
            {
              "value": "No",
              "registries": [
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            }
          ]
        },
        {
          "label": "Measuring function",
          "values": [
            {
              "value": "No",
              "registries": [
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            }
          ]
        },
        {
          "label": "Incorporates a medicinal substance",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        }
      ]
    }
  ]
}