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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Ultrasound, Intravascular
510(k) Number K261849
Device Name VERAFEYE Imaging Catheter (VF-VIC-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
Regulation Number870.1200
Classification Product Code
OBJ  
Date Received06/03/2026
Decision Date 07/24/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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