VISULAS TRION LASER SYSTEM WITH THE VITE OPTION— 510(k) K103056

Substantially Equivalent

Carl Zeiss Meditec, AG

FDA 510(k) clearance K103056 for VISULAS TRION LASER SYSTEM WITH THE VITE OPTION, Substantially Equivalent on 2011-02-01. Applicant: Carl Zeiss Meditec, AG.

Clearance details

Applicant: Carl Zeiss Meditec, AG
Product code: Code HQF
Advisory panel: Ophthalmic
Date received: 2010-10-15
Decision date: 2011-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dublin, CA, US

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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.