OPTO HYALUS GREEN LASER— 510(k) K111460

Substantially Equivalent

Opto Eletronica S/A

FDA 510(k) clearance K111460 for OPTO HYALUS GREEN LASER, Substantially Equivalent on 2012-08-20. Applicant: Opto Eletronica S/A.

Clearance details

Applicant: Opto Eletronica S/A
Product code: Code HQF
Advisory panel: Ophthalmic
Date received: 2011-05-26
Decision date: 2012-08-20
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.