510(k) K202989

Myopia Master by Oculus Optikgeräte GmbH — Product Code MXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 2021
Date Received
September 30, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Analysis, Anterior Segment
Device Class
Class II
Regulation Number
886.1850
Review Panel
OP
Submission Type