Tearscience, Inc.
Tearscience, Inc. holds FDA 510(k) medical device clearances, first cleared 2009, most recent 2019, with 2 FDA device recalls on record.
Top product codes for Tearscience, Inc.
FDA recalls by Tearscience, Inc.
- Z-1535-2017 — LipiFlow Thermal Pulsation System/LipiFlow, System Activator (Disposable), Rx Only, Sterile
- Z-0093-2017 — LipiFlow thermal Pulsation System, consisting of Console and Activator, Model LFD-1100 The LipiFlow Thermal Pulsation System is intended for use by physicians as a prescription device for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Tearscience, Inc.
- K192623 — LipiFlow Thermal Pulsation System
- K182506 — LipiScan Dynamic Meibomian Imager
- K161357 — LipiFlow Thermal Pulsation System
- K152869 — LipiView II Ocular Surface Interferometer
- K133127 — LIPIFLOW THERMAL PULSATION SYSTEM
- K122481 — LIPIVIEW OCULAR SURFACE INTERFEROMETER
- K112704 — LIPIFLOW THERMAL PULSATION SYSTEM
- DEN100017 — LIPFLOW THERMAL PULSATION SYSTEM (FORMERLY MANUAL MINI SYSTEM)
- K091935 — LIPIVIEW OCULAR SURFACE INTERFEROMETER
Data sourced from openFDA. This site is unofficial and independent of the FDA.