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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 K152869
FOIA Releasable 510(k) K152869
Device Name LipiView II Ocular Surface Interferometer
Applicant
Tearscience, Inc.
5151 Mccrimmon Pkwy.
Suite 250
Morrisville,  NC  27650
Applicant Contact CHRISTY COLEMAN
Correspondent
Tearscience, Inc.
5151 Mccrimmon Pkwy.
Suite 250
Morrisville,  NC  27650
Correspondent Contact CHRISTY COLEMAN
Regulation Number886.1120
Classification Product Code
HKI  
Subsequent Product Code
HJO  
Date Received09/30/2015
Decision Date 01/14/2016
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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