# K190359: Sonendo GentleWave System

- Pathway: 510(k) (Special)
- Applicant: Sonendo, Inc.
- Decided: Mar 16, 2019 after 29 days
- Product code: ELC (Scaler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 872.4850
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K153157 (2016). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160905: Sonendo GentleWave System, Sonendo, Inc. (2016) Summary page 4.

## Recalls of this device
- Oct 14, 2022 · Class II · Z-0233-2023: Procedure Instruments with erroneous unit carton labels.
- Oct 14, 2022 · Class II · Z-0234-2023: Procedure Instruments with erroneous unit carton labels.
- Oct 23, 2019 · Class II · Z-2162-2020: The console would continue to run for extended period when the foot pedal was released.

## Indications for use
The Sonendo GentleWave(R) System is intended to prepare, clean, and irrigate teeth indicated for root canal therapy. When used with the Sonendo GentleWave Molar Handpiece, the System is indicated for 1st and 2nd molar teeth. When used with the Sonendo GentleWave Anterior/Premolar Handpiece. the System is indicated for anterior and premolar teeth.

Source page: https://510kreport.com/device/K190359
Methodology: https://510kreport.com/methodology