Alleye

Grid, Amsler

Oculocare Medical AG

The following data is part of a premarket notification filed by Oculocare Medical Ag with the FDA for Alleye.

Pre-market Notification Details

Device IDK180895
510k NumberK180895
Device Name:Alleye
ClassificationGrid, Amsler
Applicant Oculocare Medical AG Verena Conzett Strasse 9 Zurich,  CH Zh 8004
ContactLucas Bachmann
CorrespondentAllison Komiyama
AcKnowledge Regulatory Strategies, LLC 2834 Hawthorn St. San Diego,  CA  92104
Product CodeHOQ  
CFR Regulation Number886.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-04-05
Decision Date2018-06-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
EOMA32120 K180895 000

Trademark Results [Alleye]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ALLEYE
ALLEYE
79327169 not registered Live/Pending
Oculocare medical AG
2021-08-10

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