OPTIMEDICA CATALYS PRECISION LASER SYSTEM— 510(k) K141079

Substantially Equivalent

Optimedica Corporation

FDA 510(k) clearance K141079 for OPTIMEDICA CATALYS PRECISION LASER SYSTEM, Substantially Equivalent on 2014-09-11. Applicant: Optimedica Corporation.

Clearance details

Applicant: Optimedica Corporation
Product code: Code OOE
Advisory panel: Ophthalmic
Date received: 2014-04-25
Decision date: 2014-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

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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.