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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Analysis, Anterior Segment
510(k) Number K202989
Device Name Myopia Master
Applicant
OCULUS Optikgeräte GmbH
Münchholzhäuser Straße 29
Wetzlar,  DE 35582
Applicant Contact Eckhard Loh
Correspondent
Hogan Lovells US LLP
555 Thirteenth Street NW
Washington,  DC  20004
Correspondent Contact Randy Prebula
Regulation Number886.1850
Classification Product Code
MXK  
Date Received09/30/2020
Decision Date 07/14/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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