Myopia Master

Device, Analysis, Anterior Segment

OCULUS Optikgeräte GmbH

The following data is part of a premarket notification filed by Oculus Optikgeräte Gmbh with the FDA for Myopia Master.

Pre-market Notification Details

Device IDK202989
510k NumberK202989
Device Name:Myopia Master
ClassificationDevice, Analysis, Anterior Segment
Applicant OCULUS Optikgeräte GmbH Münchholzhäuser Straße 29 Wetzlar,  DE 35582
ContactEckhard Loh
CorrespondentRandy Prebula
Hogan Lovells US LLP 555 Thirteenth Street NW Washington,  DC  20004
Product CodeMXK  
CFR Regulation Number886.1850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-30
Decision Date2021-07-14

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04049584029959 K202989 000
04049584029942 K202989 000

Trademark Results [Myopia Master]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MYOPIA MASTER
MYOPIA MASTER
79262965 not registered Live/Pending
Oculus Optikgeräte GmbH
2019-03-18

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