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FDA 510(k)

Zilia Ocular FC (ZIL-10002)

K-Number: K230627 · 2023-11-20

ApplicantZilia, Inc.
Decision Date2023-11-20
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Zilia Ocular FC (ZIL-10002) is the device name listed in this FDA 510(k) record. The listed applicant is Zilia, Inc.. It received FDA 510(k) clearance on 2023-11-20 under 510(k) number K230627. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Zilia Ocular FC (ZIL-10002)?

Zilia Ocular FC (ZIL-10002) is a medical device that received FDA 510(k) clearance on 2023-11-20. The listed applicant is Zilia, Inc.. The 510(k) number is K230627.

When did Zilia Ocular FC (ZIL-10002) receive FDA 510(k) clearance?

Zilia Ocular FC (ZIL-10002) received FDA 510(k) clearance on 2023-11-20, under 510(k) number K230627.

Who is the listed applicant for Zilia Ocular FC (ZIL-10002)?

The FDA 510(k) record lists Zilia, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Zilia Ocular FC (ZIL-10002)?

The FDA product code for Zilia Ocular FC (ZIL-10002) is HKI.

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Official Source

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