Zilia Ocular FC (ZIL-10002)— 510(k) K230627

Substantially Equivalent

Zilia, Inc.

FDA 510(k) clearance K230627 for Zilia Ocular FC (ZIL-10002), Substantially Equivalent on 2023-11-20. Applicant: Zilia, Inc.. Device class: 2.

Clearance details

Applicant: Zilia, Inc.
Product code: Code HKI
Device class: Class 2
Regulation: 21 CFR 886.1120
Advisory panel: Ophthalmic
Date received: 2023-03-06
Decision date: 2023-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Quebec City, CA

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.