K260885
- 510(k) number
- K260885
- Device name
- VERAFEYE Imaging and Guidance System (VF-VIS-002)
- Applicant
- Luma Vision Limited IE
- Decision date
- 2026-06-15
- Date received
- 2026-03-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K260885.pdf
Official FDA record: K260885
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.