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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 a medical device manufactured by Zilia, Inc.. It received FDA 510(k) clearance on 2023-11-20 under approval 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. It is manufactured by Zilia, Inc.. The 510(k) number is K230627.

When was Zilia Ocular FC (ZIL-10002) approved by the FDA?

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

What company makes Zilia Ocular FC (ZIL-10002)?

Zilia Ocular FC (ZIL-10002) is manufactured by Zilia, Inc..

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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