Medical Device Manufacturer · US , Morrisville , NC

Tearscience, Inc. - FDA 510(k) Cleared Devices

9 submissions · 8 cleared · Since 2009

Recent clearances: LipiFlow Thermal Pulsation System, LipiScan Dynamic Meibomian Imager

9
Total
8
Cleared
1
Denied

FDA 510(k) Regulatory Record - Tearscience, Inc. Ophthalmic ✕

9 devices
1-9 of 9
Cleared Oct 22, 2019
LipiFlow Thermal Pulsation System
K192623 · ORZ
Ophthalmic · 29d
Cleared Dec 10, 2018
LipiScan Dynamic Meibomian Imager
K182506 · HKI
Ophthalmic · 89d
Cleared Nov 04, 2016
LipiFlow Thermal Pulsation System
K161357 · ORZ
Ophthalmic · 172d
Cleared Jan 14, 2016
LipiView II Ocular Surface Interferometer
K152869 · HKI
Ophthalmic · 106d
Cleared Dec 23, 2013
LIPIFLOW THERMAL PULSATION SYSTEM
K133127 · ORZ
Ophthalmic · 84d
Cleared Dec 31, 2012
LIPIVIEW OCULAR SURFACE INTERFEROMETER
K122481 · HKI
Ophthalmic · 139d
Cleared Dec 19, 2011
LIPIFLOW THERMAL PULSATION SYSTEM
K112704 · ORZ
Ophthalmic · 94d
Not Cleared Jun 28, 2011
LIPFLOW THERMAL PULSATION SYSTEM (FORMERLY MANUAL MINI SYSTEM)
DEN100017 · ORZ
Ophthalmic · 323d
Cleared Oct 23, 2009
LIPIVIEW OCULAR SURFACE INTERFEROMETER
K091935 · HKI
Ophthalmic · 115d
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