{
  "format": "devicerts.device.v1",
  "cite_as": "Sonendo GentleWave System, Sonendo, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/sonendo-gentlewave-system-elc (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/sonendo-gentlewave-system-elc",
    "json_url": "https://devicerts.com/devices/sonendo-gentlewave-system-elc.json",
    "markdown_url": "https://devicerts.com/devices/sonendo-gentlewave-system-elc.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      },
      {
        "registry": "FDA recalls",
        "url": "https://open.fda.gov/apis/device/recall/"
      }
    ],
    "registry_records_last_synced": "2026-10-22",
    "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/sonendo-gentlewave-system-elc",
    "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": "Sonendo GentleWave System",
    "registry_name": "Sonendo GentleWave System",
    "url": "https://devicerts.com/devices/sonendo-gentlewave-system-elc",
    "manufacturer": {
      "name": "Sonendo, Inc.",
      "url": "https://devicerts.com/manufacturers/sonendo-inc",
      "country": "United States",
      "country_basis": "FDA 510(k) applicant",
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "United States"
    },
    "classification": [
      {
        "class": "Class II",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K190359",
            "registries": [
              "FDA 510(k)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "ELC"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The Sonendo GentleWave System is a dental device classified as a scaler, ultrasonic. It is designed for use in dental procedures to perform scaling functions.\n\nThe device is manufactured by Sonendo, Inc. and received FDA 510(k) clearance with the K number K190359 on March 16, 2019. It is registered under multiple registration numbers and falls under product code ELC with regulation number 872.4850. The device is intended for dental use as indicated by its advisory committee classification.",
      "ai_generated": true,
      "generated_on": "2026-09-23",
      "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": "K190359",
      "number_label": null,
      "device_udi_di": null,
      "date": "2019-03-16",
      "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": [
    {
      "number": "Z-0233-2023",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2022-10-14",
      "reason": "Procedure Instruments with erroneous unit carton labels.",
      "applies": "this device",
      "via": "K190359"
    },
    {
      "number": "Z-0234-2023",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2022-10-14",
      "reason": "Procedure Instruments with erroneous unit carton labels.",
      "applies": "this device",
      "via": "K190359"
    },
    {
      "number": "Z-2162-2020",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2019-10-23",
      "reason": "The console would continue to run for extended period when the foot pedal was released.",
      "applies": "this device",
      "via": "K190359"
    }
  ],
  "eu_market_availability": null,
  "properties": [
    {
      "group": "Identifiers",
      "fields": [
        {
          "label": "510(k) Number",
          "values": [
            {
              "value": "K190359",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA product code",
          "values": [
            {
              "value": "ELC",
              "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 872.4850",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Advisory committee",
          "values": [
            {
              "value": "Dental",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA decision",
          "values": [
            {
              "value": "SESE",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        }
      ]
    }
  ]
}