Alleye
K-Number: K180895 · 2018-06-27
ApplicantOculocare Medical AG
Decision Date2018-06-27
Product CodeHOQ
Advisory CommitteeOP
DecisionSubstantially Equivalent
Device Summary
Alleye is the device name listed in this FDA 510(k) record. The listed applicant is Oculocare Medical AG. It received FDA 510(k) clearance on 2018-06-27 under 510(k) 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. The listed applicant is Oculocare Medical AG. The 510(k) number is K180895.
When did Alleye receive FDA 510(k) clearance?
Alleye received FDA 510(k) clearance on 2018-06-27, under 510(k) number K180895.
Who is the listed applicant for Alleye?
The FDA 510(k) record lists Oculocare Medical AG as the applicant. This does not by itself establish the device manufacturer.
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.