K243878
- 510(k) number
- K243878
- Device name
- CLARUS (700)
- Applicant
- Carl Zeiss Meditec, Inc. CA · US
- Product code
- QER — Camera, Ophthalmic, Slit-Scanning
- Decision date
- 2025-04-17
- Date received
- 2024-12-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ophthalmic
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K243878.pdf
Official FDA record: K243878
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.