SONENDO ENDOTHERAPY SYSTEM— 510(k) K130025

Substantially Equivalent

Sonendo, Inc.

FDA 510(k) clearance K130025 for SONENDO ENDOTHERAPY SYSTEM, Substantially Equivalent on 2013-06-11. Applicant: Sonendo, Inc..

Clearance details

Applicant: Sonendo, Inc.
Product code: Code ELC
Advisory panel: Dental
Date received: 2013-01-03
Decision date: 2013-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laguna Hills, CA, US

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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.