Sonendo GentleWave System— 510(k) K143448

Name: FDA 510(k) clearance K143448
Creator: U.S. Food and Drug Administration
Published: 2015-05-01

Substantially Equivalent

Sonendo, Inc.

FDA 510(k) clearance K143448 for Sonendo GentleWave System, Substantially Equivalent on 2015-05-01. Applicant: Sonendo, Inc.. Device class: 2.

Clearance details

Applicant: Sonendo, Inc.
Product code: Code ELC
Device class: Class 2
Regulation: 21 CFR 872.4850
Advisory panel: Dental
Date received: 2014-12-02
Decision date: 2015-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laguna Hills, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code ELC

product code ELC

Malfunction: 1,255
Total: 1,255

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.