EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector)— 510(k) K190875

Substantially Equivalent

D.O.R.C. Dutch Ophthalmic Research Center (International)

FDA 510(k) clearance K190875 for EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector), Substantially Equivalent on 2019-09-25. Applicant: D.O.R.C. Dutch Ophthalmic Research Center (International).

Clearance details

Applicant: D.O.R.C. Dutch Ophthalmic Research Center (International)
Product code: Code HQC
Advisory panel: Ophthalmic
Date received: 2019-04-04
Decision date: 2019-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zuidland, NL

Download summary PDF View on FDA.gov ↗

Adverse events under product code HQC

product code HQC

Injury: 2,378
Malfunction: 8,768
Total: 11,146

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.