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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 K172645
Device Name iLux Instrument, iLux Disposable
Applicant
Tear Film Innovations, Inc.
12625 High Bluff Drive, Suite 107
San Diego,  CA  92130
Applicant Contact John Slate
Correspondent
Tear Film Innovations, Inc.
12625 High Bluff Drive, Suite 107
San Diego,  CA  92130
Correspondent Contact John Slate
Regulation Number886.5200
Classification Product Code
ORZ  
Date Received09/01/2017
Decision Date 12/26/2017
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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