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 a medical device manufactured by Eyenez, LLC. It received FDA 510(k) clearance on 2016-10-04 under approval 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. It is manufactured by Eyenez, LLC. The 510(k) number is K161727.
When was Eyenez Ophthalmic Camera approved by the FDA?
Eyenez Ophthalmic Camera received FDA 510(k) clearance on 2016-10-04, under approval number K161727.
What company makes Eyenez Ophthalmic Camera?
Eyenez Ophthalmic Camera is manufactured by Eyenez, LLC.
What is the FDA product code for Eyenez Ophthalmic Camera?
The FDA product code for Eyenez Ophthalmic Camera is HKI.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.