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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Ophthalmic
510(k) Number K181682
Device Name VISULAS green
Applicant
Carl Zeiss Meditec, AG
Goeschwitzer Strasse 51-52
Jena,  DE 07445
Applicant Contact Christian Munster
Correspondent
Biologics Consulting Group, Inc.
1555 King St.,
Suite 300
Alexandria,  VA  22314
Correspondent Contact Lisa Graney
Regulation Number886.4390
Classification Product Code
HQF  
Subsequent Product Code
GEX  
Date Received06/26/2018
Decision Date 03/06/2019
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
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