510(k) K260885
K260885 is an FDA 510(k) premarket notification submitted by Luma Vision Limited for the device "VERAFEYE Imaging and Guidance System (VF-VIS-002)". The FDA issued a decision of Substantially Equivalent on June 15, 2026. Luma Vision Limited has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 15, 2026
- Date Received
- March 17, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No