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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Eyelid Thermal Pulsation System
510(k) Number K200400
Device Name Systane iLux2
Applicant
Tear Film Innovations, Inc.
5924 Balfour Ct., Suite 100
Carlsbad,  CA  92008
Applicant Contact Neal Hartman
Correspondent
Tear Film Innovations, Inc.
5924 Balfour Ct., Suite 100
Carlsbad,  CA  92008
Correspondent Contact Neal Hartman
Regulation Number886.5200
Classification Product Code
ORZ  
Date Received02/18/2020
Decision Date 05/21/2020
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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