K253834
- 510(k) number
- K253834
- Device name
- VISUREF 600
- Applicant
- Carl Zeiss Vision GmbH DE
- Product code
- HJO — Biomicroscope, Slit-Lamp, Ac-Powered
- Decision date
- 2026-03-18
- Date received
- 2025-12-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ophthalmic
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K253834.pdf
Official FDA record: K253834
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.