510(k) Report

Devices descending from DEN100017

12 later devices reach Lipflow Thermal Pulsation System (Formerly Manual Mini System) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161357LipiFlow Thermal Pulsation SystemTearscience, Inc.201671
+1K133127Lipiflow Thermal Pulsation SystemTearscience, Inc.2013102
+1K112704Lipiflow Thermal Pulsation SystemTearscience, Inc.2011112
+2K213045TearCare SystemSight Sciences, Inc.20215—
+2K192623LipiFlow Thermal Pulsation SystemTearscience, Inc.20191—
+2K172645iLux Instrument, iLux DisposableTear Film Innovations, Inc.20172—
+3K240512Tixel i (TXLI0001)Novoxel, Ltd.20240—
+3K231084TearCare MGX SystemSight Sciences, Inc.20234—
+3K200400Systane iLux2Tear Film Innovations, Inc.20200—
+4K242786TearCare MGX SystemSight Sciences, Inc.20252—
+5K252409TearCare MGX SystemSight Sciences, Inc.20261—
+6K262479TearCare SystemSight Sciences, Inc.20260—