VERAFEYE Imaging and Guidance System (VF-VIS-002)
FDA 510(k) clearance K260885 · decided 2026-06-15
Clearance details
- K-number
- K260885
- Device name
- VERAFEYE Imaging and Guidance System (VF-VIS-002)
- Applicant
- Luma Vision Limited
- Decision
- Substantially Equivalent
- Date received
- 2026-03-17
- Decision date
- 2026-06-15
- Days to decision
- 90 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Dublin, IE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.