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Sonendo GentleWave System

by Sonendo, Inc. 3 variants

510(k) K190359

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK190359 Date16 Mar 2019ClearedStatusActive

Official records

Recalls

3 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-0233-2023 FDA Class II initiated 14 Oct 2022
    • Ongoing Z-0234-2023 FDA Class II initiated 14 Oct 2022

    Procedure Instruments with erroneous unit carton labels.

    • Terminated Z-2162-2020 FDA Class II initiated 23 Oct 2019

    The console would continue to run for extended period when the foot pedal was released.

Timeline

4 dated events

  1. Cleared FDA 510(k) K190359
  2. Recall initiated FDA recalls Z-2162-2020
  3. Recall initiated FDA recalls Z-0233-2023
  4. Recall initiated FDA recalls Z-0234-2023

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
ELC
Device class
Class II
Regulation
21 CFR Part 872.4850
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

The 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.

Similar devices

Other devices filed under FDA product code ELC (Scaler, Ultrasonic).

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