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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Ophthalmic, Ac-Powered
510(k) Number K161727
Device Name Eyenez Ophthalmic Camera
Applicant
Eyenez, LLC
2619 E.Colorado Blvd.
Pasadena,  CA  91107
Applicant Contact DR. KISLINGER
Correspondent
Accurate Consultants, Inc.
3234 Ibis St.
San Diego,  CA  92103
Correspondent Contact GLEN FEYE
Regulation Number886.1120
Classification Product Code
HKI  
Date Received06/22/2016
Decision Date 10/04/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Clinical Trials NCT02783807
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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