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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 K091935
Device Name LIPIVIEW OCULAR SURFACE INTERFEROMETER
Applicant
Tearscience, Inc.
1101 G Aviation Pkwy.
Morrisville,  NC  27560
Applicant Contact CHRISTY STEVENS
Correspondent
Tearscience, Inc.
1101 G Aviation Pkwy.
Morrisville,  NC  27560
Correspondent Contact CHRISTY STEVENS
Regulation Number886.1120
Classification Product Code
HKI  
Subsequent Product Code
HJO  
Date Received06/30/2009
Decision Date 10/23/2009
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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