510(k) K260885

VERAFEYE Imaging and Guidance System (VF-VIS-002) by Luma Vision Limited

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