Tearscience, Inc
FDA Regulatory Profile
Tearscience, Inc appears in FDA public data with 2 recalls, 9 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-1535-2017, Class II) was initiated on January 30, 2017. Its most recent 510(k) clearance was granted on October 22, 2019.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 9
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1535-2017 | Class II | LipiFlow Thermal Pulsation System/LipiFlow, System Activator (Disposable), Rx Only, Sterile | January 30, 2017 |
| Z-0093-2017 | Class II | LipiFlow thermal Pulsation System, consisting of Console and Activator, Model LFD-1100 The LipiFl | September 13, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K192623 | LipiFlow Thermal Pulsation System | October 22, 2019 |
| K182506 | LipiScan Dynamic Meibomian Imager | December 10, 2018 |
| K161357 | LipiFlow Thermal Pulsation System | November 4, 2016 |
| K152869 | LipiView II Ocular Surface Interferometer | January 14, 2016 |
| K133127 | LIPIFLOW THERMAL PULSATION SYSTEM | December 23, 2013 |
| K122481 | LIPIVIEW OCULAR SURFACE INTERFEROMETER | December 31, 2012 |
| K112704 | LIPIFLOW THERMAL PULSATION SYSTEM | December 19, 2011 |
| DEN100017 | LIPFLOW THERMAL PULSATION SYSTEM (FORMERLY MANUAL MINI SYSTEM) | June 28, 2011 |
| K091935 | LIPIVIEW OCULAR SURFACE INTERFEROMETER | October 23, 2009 |