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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K260885
Device Name VERAFEYE Imaging and Guidance System (VF-VIS-002)
Applicant
Luma Vision Limited
Block C, Parkview House-Beech Hill Office Campus
Beech Hill Rd.
Dublin,  IE D04 K5D0
Applicant Contact Marta Walker
Correspondent
Luma Vision Limited
Block C, Parkview House-Beech Hill Office Campus
Beech Hill Rd.
Dublin,  IE D04 K5D0
Correspondent Contact Marta Walker
Date Received03/17/2026
Decision Date 06/15/2026
Decision Substantially Equivalent (SESE)
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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