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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Grid, Amsler
510(k) Number K180895
Device Name Alleye
Applicant
Oculocare Medical AG
Verena Conzett Strasse 9
Zurich,  CH ZH 8004
Applicant Contact Lucas Bachmann
Correspondent
Acknowledge Regulatory Strategies, LLC
2834 Hawthorn St.
San Diego,  CA  92104
Correspondent Contact Allison Komiyama
Regulation Number886.1330
Classification Product Code
HOQ  
Date Received04/05/2018
Decision Date 06/27/2018
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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