VERAFEYE Imaging and Guidance System (VF-VIS-002)

FDA 510(k) K260885 · Luma Vision Limited

Substantially Equivalent

510(k) numberK260885

Submission

Device name
VERAFEYE Imaging and Guidance System (VF-VIS-002)
Applicant
Luma Vision Limited
Dublin, IE
Received
March 17, 2026
Decision date
June 15, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

No product code recorded.

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Questions and answers

When was VERAFEYE Imaging and Guidance System (VF-VIS-002) cleared by the FDA?

VERAFEYE Imaging and Guidance System (VF-VIS-002) (K260885) received a 510(k) decision of Substantially Equivalent on June 15, 2026, 90 days after the submission was received.