# K153157: Sonendo Gentle Wave System

- Pathway: 510(k) (Special)
- Applicant: Sonendo, Inc.
- Decided: Jan 29, 2016 after 88 days
- Product code: ELC (Scaler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 872.4850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K160905: Sonendo GentleWave System (2016), 2 descendants of its own
- K203302: GentleWave X (2021), 0 descendants of its own
- K190359: Sonendo GentleWave System (2019), 0 descendants of its own

## Indications for use
The Sonendo GentleWave™ System is intended to prepare, clean, and irmigate 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/K153157
Methodology: https://510kreport.com/methodology