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Tearscience, Inc

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
9
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1535-2017Class IILipiFlow Thermal Pulsation System/LipiFlow, System Activator (Disposable), Rx Only, SterileJanuary 30, 2017
Z-0093-2017Class IILipiFlow thermal Pulsation System, consisting of Console and Activator, Model LFD-1100 The LipiFlSeptember 13, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K192623LipiFlow Thermal Pulsation SystemOctober 22, 2019
K182506LipiScan Dynamic Meibomian ImagerDecember 10, 2018
K161357LipiFlow Thermal Pulsation SystemNovember 4, 2016
K152869LipiView II Ocular Surface InterferometerJanuary 14, 2016
K133127LIPIFLOW THERMAL PULSATION SYSTEMDecember 23, 2013
K122481LIPIVIEW OCULAR SURFACE INTERFEROMETERDecember 31, 2012
K112704LIPIFLOW THERMAL PULSATION SYSTEMDecember 19, 2011
DEN100017LIPFLOW THERMAL PULSATION SYSTEM (FORMERLY MANUAL MINI SYSTEM)June 28, 2011
K091935LIPIVIEW OCULAR SURFACE INTERFEROMETEROctober 23, 2009