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FDA 510(k)

Eyenez Ophthalmic Camera

K-Number: K161727 · 2016-10-04

ApplicantEyenez, LLC
Decision Date2016-10-04
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Eyenez Ophthalmic Camera is the device name listed in this FDA 510(k) record. The listed applicant is Eyenez, LLC. It received FDA 510(k) clearance on 2016-10-04 under 510(k) number K161727. 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 Eyenez Ophthalmic Camera?

Eyenez Ophthalmic Camera is a medical device that received FDA 510(k) clearance on 2016-10-04. The listed applicant is Eyenez, LLC. The 510(k) number is K161727.

When did Eyenez Ophthalmic Camera receive FDA 510(k) clearance?

Eyenez Ophthalmic Camera received FDA 510(k) clearance on 2016-10-04, under 510(k) number K161727.

Who is the listed applicant for Eyenez Ophthalmic Camera?

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

What is the FDA product code for Eyenez Ophthalmic Camera?

The FDA product code for Eyenez Ophthalmic Camera is HKI.

Related Devices (Code: HKI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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