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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name biomicroscope, slit-lamp, ac-powered
510(k) Number K122481
Model LVI-1000, LVI-1001
Device Name LIPIVIEW OCULAR SURFACE INTERFEROMETER
Original Applicant
TEARSCIENCE, INC.
5151 mccrimmon pkwy ste 250
morrisville,  NC  27560
Original Contact christy stevens
Regulation Number886.1850
Classification Product Code
HJO  
Subsequent Product Code
HKI  
Date Received08/14/2012
Decision Date 12/31/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Ophthalmic
Review Advisory Committee Ophthalmic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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