510(k) K220516— CATALYS Precision Laser system

Substantially Equivalent

Amo Manufacturing USA, LLC

Clearance details

Applicant: Amo Manufacturing USA, LLC
Product code: Code OOE
Advisory panel: Ophthalmic
Date received: 2022-02-23
Decision date: 2022-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milpitas, CA, US

Adverse events under product code OOE

product code OOE

Injury: 1,104
Malfunction: 864
Total: 1,968

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.