510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K260885Substantially Equivalent

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

Luma Vision Limited, Dublin, IE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K260885 is the FDA 510(k) clearance record for VERAFEYE Imaging and Guidance System (VF-VIS-002), cleared for Luma Vision Limited on . FDA records list 3 510(k) clearances for Luma Vision Limited, from to . As of , FDA records show no recalls naming K260885.

Clearance record

Decision date
Received
(90 days to decision)
Review panel
Unknown
Applicant
Luma Vision Limited Block C, Parkview House-Beech Hill Office Campus, Dublin, IE
510(k) summary
Summary PDF
Third party review
No