510(k) Report

Devices descending from K161357

7 later devices reach LipiFlow Thermal Pulsation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213045TearCare SystemSight Sciences, Inc.20215—
+1K192623LipiFlow Thermal Pulsation SystemTearscience, Inc.20191—
+2K240512Tixel i (TXLI0001)Novoxel, Ltd.20240—
+2K231084TearCare MGX SystemSight Sciences, Inc.20234—
+3K242786TearCare MGX SystemSight Sciences, Inc.20252—
+4K252409TearCare MGX SystemSight Sciences, Inc.20261—
+5K262479TearCare SystemSight Sciences, Inc.20260—