FDA 510(k) clearance · back to tracker

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

Luma Vision Limited cleared K260885 on 2026-06-15, decision: substantially equivalent

K-number

K260885

Sponsor

Luma Vision Limited

Device

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

Class

Not specified

Decision

Substantially Equivalent

Decision date

2026-06-15

Product code

Advisory committee

Unknown

Medical specialty

Regulation number

Official FDA record

Open K260885on accessdata.fda.gov →

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

openFDA JSON

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.