Alleye
K-Number: K180895 · 2018-06-27
ApplicantOculocare Medical AG
Decision Date2018-06-27
Product CodeHOQ
Advisory CommitteeOP
DecisionSubstantially Equivalent
Device Summary
Alleye is a medical device manufactured by Oculocare Medical AG. It received FDA 510(k) clearance on 2018-06-27 under approval number K180895. The device is classified under product code HOQ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Alleye?
Alleye is a medical device that received FDA 510(k) clearance on 2018-06-27. It is manufactured by Oculocare Medical AG. The 510(k) number is K180895.
When was Alleye approved by the FDA?
Alleye received FDA 510(k) clearance on 2018-06-27, under approval number K180895.
What company makes Alleye?
Alleye is manufactured by Oculocare Medical AG.
What is the FDA product code for Alleye?
The FDA product code for Alleye is HOQ.
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.