The following data is part of a premarket notification filed by Tearscience, Inc. with the FDA for Lipiflow Thermal Pulsation System.
| Device ID | K161357 |
| 510k Number | K161357 |
| Device Name: | LipiFlow Thermal Pulsation System |
| Classification | Eyelid Thermal Pulsation System |
| Applicant | TEARSCIENCE, INC. 5151 MCCRIMMON PARKWAY SUITE 250 Morrisville, NC 27560 |
| Contact | Christy Coleman |
| Correspondent | Christy Coleman TEARSCIENCE, INC. 5151 MCCRIMMON PARKWAY SUITE 250 Morrisville, NC 27560 |
| Product Code | ORZ |
| CFR Regulation Number | 886.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-16 |
| Decision Date | 2016-11-04 |
| Summary: | summary |