VISULAS yag— 510(k) K230350

Substantially Equivalent

Carl Zeiss Meditec, Inc.

FDA 510(k) clearance K230350 for VISULAS yag, Substantially Equivalent on 2023-09-22. Applicant: Carl Zeiss Meditec, Inc..

Clearance details

Applicant: Carl Zeiss Meditec, Inc.
Product code: Code HQF
Advisory panel: Ophthalmic
Date received: 2023-02-09
Decision date: 2023-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dublin, CA, US

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.