510(k) Report

Devices descending from K213045

5 later devices reach TearCare System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231084TearCare MGX SystemSight Sciences, Inc.20234—
+2K242786TearCare MGX SystemSight Sciences, Inc.20252—
+2K240512Tixel i (TXLI0001)Novoxel, Ltd.20240—
+3K252409TearCare MGX SystemSight Sciences, Inc.20261—
+4K262479TearCare SystemSight Sciences, Inc.20260—