Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse— 510(k) K231011

Substantially Equivalent

Meridian AG

FDA 510(k) clearance K231011 for Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse, Substantially Equivalent on 2023-09-12. Applicant: Meridian AG.

Clearance details

Applicant: Meridian AG
Product code: Code HQF
Advisory panel: Ophthalmic
Date received: 2023-04-10
Decision date: 2023-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Thun, CH

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.