Visalis V500, Visalis S500— 510(k) K193376
Substantially EquivalentCarl Zeiss Meditec, AG
FDA 510(k) clearance K193376 for Visalis V500, Visalis S500, Substantially Equivalent on 2020-06-15. Applicant: Carl Zeiss Meditec, AG.
Clearance details
- Applicant
- Carl Zeiss Meditec, AG
- Product code
- Code HQC
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Jena, DE
Adverse events under product code HQC
product code HQC- Injury
- 2,378
- Malfunction
- 8,768
- Total
- 11,146
Source: openFDA MAUDE database, through . 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.