GentleWave X— 510(k) K203302

Substantially Equivalent

Sonendo, Inc.

FDA 510(k) clearance K203302 for GentleWave X, Substantially Equivalent on 2021-02-05. Applicant: Sonendo, Inc..

Clearance details

Applicant: Sonendo, Inc.
Product code: Code ELC
Advisory panel: Dental
Date received: 2020-11-09
Decision date: 2021-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laguna Hills, CA, US

Download summary PDF View on FDA.gov ↗

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.