Company ยท US
Tearscience, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2009 to 2019. Name variants (Inc, Corp, punctuation) are merged.
9510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 22, 2019 | K192623 | LipiFlow Thermal Pulsation System Tearscience, Inc. | ORZ |
| Dec 10, 2018 | K182506 | LipiScan Dynamic Meibomian Imager Tearscience, Inc. | HKI |
| Nov 4, 2016 | K161357 | LipiFlow Thermal Pulsation System Tearscience, Inc. | ORZ |
| Jan 14, 2016 | K152869 | LipiView II Ocular Surface Interferometer Tearscience, Inc. | HKI |
| Dec 23, 2013 | K133127 | LIPIFLOW THERMAL PULSATION SYSTEM Tearscience, Inc. | ORZ |
| Dec 31, 2012 | K122481 | LIPIVIEW OCULAR SURFACE INTERFEROMETER Tearscience, Inc. | HKI |
| Dec 19, 2011 | K112704 | LIPIFLOW THERMAL PULSATION SYSTEM Tearscience, Inc. | ORZ |
| Jun 28, 2011 | DEN100017 | LIPFLOW THERMAL PULSATION SYSTEM (FORMERLY MANUAL MINI SYSTEM) Tearscience, Inc. | ORZ |
| Oct 23, 2009 | K091935 | LIPIVIEW OCULAR SURFACE INTERFEROMETER Tearscience, Inc. | HKI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 22, 2017 | Tearscience, Inc LipiFlow Thermal Pulsation System/LipiFlow, System Activator (Disposable), Rx Only, Sterile Terminated |
ORZ | K112704 K133127 +1 |
| Oct 17, 2016 | Tearscience, Inc 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 applica Terminated |
ORZ | K112704 K133127 |