{
  "format": "devicerts.device.v1",
  "cite_as": "CellFX System, Pulse Biosciences, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/cellfx-r-system-gei (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/cellfx-r-system-gei",
    "json_url": "https://devicerts.com/devices/cellfx-r-system-gei.json",
    "markdown_url": "https://devicerts.com/devices/cellfx-r-system-gei.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      }
    ],
    "registry_records_last_synced": "2026-11-08",
    "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/cellfx-r-system-gei",
    "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": "CellFX System",
    "registry_name": "CellFX® System",
    "url": "https://devicerts.com/devices/cellfx-r-system-gei",
    "manufacturer": {
      "name": "Pulse Biosciences, Inc",
      "url": "https://devicerts.com/manufacturers/pulse-biosciences-inc",
      "country": null,
      "country_basis": null,
      "fda_registration_country": "United States"
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "United States"
    },
    "classification": [
      {
        "class": "Class II",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K221671",
            "registries": [
              "FDA 510(k)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "GEI"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The CellFX System is a Nanosecond Pulsed Field Ablation (nsPFA) Percutaneous Electrode System, designed for non-thermal cell ablation. This device leverages proprietary nanosecond pulse technology to selectively target and clear cells while preserving surrounding tissue integrity, primarily within the realm of plastic surgery applications. Its mechanism distinguishes it from traditional thermal ablation methods by delivering precise, non-thermal energy to achieve cellular disruption.\n\nThe CellFX System is intended for percutaneous use and is supplied as a reusable medical device. It is cleared by the FDA under 510(k) clearance (K221671) as substantially equivalent to existing devices in the General, Plastic Surgery category. The system is not classified as MRI-safe or MRI-conditional, and its sterility, single-use or reusable status is not explicitly detailed in the regulatory submission. Storage and handling instructions are not provided in the available data.",
      "ai_generated": true,
      "generated_on": "2026-09-20",
      "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": "K221671",
      "number_label": null,
      "device_udi_di": null,
      "date": "2022-08-01",
      "date_kind": "decision",
      "decision_code": "SESE",
      "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": "Identifiers",
      "fields": [
        {
          "label": "510(k) Number",
          "values": [
            {
              "value": "K221671",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA product code",
          "values": [
            {
              "value": "GEI",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Classification",
      "fields": [
        {
          "label": "Device class",
          "values": [
            {
              "value": "Class II",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Regulation",
          "values": [
            {
              "value": "21 CFR Part 878.4400",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Advisory committee",
          "values": [
            {
              "value": "General, Plastic Surgery",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA decision",
          "values": [
            {
              "value": "SESE",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        }
      ]
    }
  ]
}