FDA 510(k) clearance · back to tracker

VERAFEYE Imaging Catheter (VF-VIC-002)

Luma Vision Limited cleared K261849 on 2026-07-24, decision: substantially equivalent

K-number

K261849

Sponsor

Luma Vision Limited

Device

VERAFEYE Imaging Catheter (VF-VIC-002)

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-07-24

Product code

OBJ

Advisory committee

Cardiovascular

Medical specialty

Cardiovascular

Regulation number

870.1200

Official FDA record

Open K261849on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.