510(k) K180895

Alleye by Oculocare Medical AG — Product Code HOQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 2018
Date Received
April 5, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Grid, Amsler
Device Class
Class I
Regulation Number
886.1330
Review Panel
OP
Submission Type