K123337

Substantially Equivalent

VERTESSA LITE 10 X 20CM, VERTESSA LITE 11 X 30CM

Applicant: Caldera Medical
Product code: OTO
Advisory panel: General, Plastic Surgery
Date received: 2012-10-31
Decision date: 2013-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Agoura Hills, CA, US

Adverse events under product code OTO

product code OTO

Injury: 840
Total: 840

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.