The following data is part of a premarket notification filed by Tearscience Inc. with the FDA for Lipiflow Thermal Pulsation System.
| Device ID | K192623 |
| 510k Number | K192623 |
| Device Name: | LipiFlow Thermal Pulsation System |
| Classification | Eyelid Thermal Pulsation System |
| Applicant | TearScience Inc. 1700 East St. Andrew Place Santa Ana, CA 92705 |
| Contact | Michelle Ricafort |
| Correspondent | Michelle Ricafort TearScience Inc. 1700 East St. Andrew Place Santa Ana, CA 92705 |
| Product Code | ORZ |
| CFR Regulation Number | 886.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-23 |
| Decision Date | 2019-10-22 |
| Summary: | summary |