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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 K182506
Device Name LipiScan Dynamic Meibomian Imager
Applicant
TearScience, Inc.
5151 McCrimmon Pkwy.
Ste. 250
Morrisville,  NC  27560
Applicant Contact Christy Coleman
Correspondent
TearScience, Inc.
5151 McCrimmon Pkwy.
Ste. 250
Morrisville,  NC  27560
Correspondent Contact Christy Coleman
Regulation Number886.1120
Classification Product Code
HKI  
Date Received09/12/2018
Decision Date 12/10/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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