OPTO MITRA YELLOW LASER— 510(k) K111643

Substantially Equivalent

Opto Electronica SA

FDA 510(k) clearance K111643 for OPTO MITRA YELLOW LASER, Substantially Equivalent on 2011-11-03. Applicant: Opto Electronica SA.

Clearance details

Applicant: Opto Electronica SA
Product code: Code HQF
Advisory panel: Ophthalmic
Date received: 2011-06-13
Decision date: 2011-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sao Carlos, Sao Paulo, BR

Download summary PDF View on FDA.gov ↗

Adverse events under product code HQF

product code HQF

Injury: 166
Other: 1
Total: 167

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.