The following data is part of a premarket notification filed by Tearscience, Inc. with the FDA for Lipiflow Thermal Pulsation System.
| Device ID | K112704 |
| 510k Number | K112704 |
| Device Name: | LIPIFLOW THERMAL PULSATION SYSTEM |
| Classification | Eyelid Thermal Pulsation System |
| Applicant | TEARSCIENCE, INC. 5151 MCCRIMMON PARKWAY SUITE 250 Morrisville, NC 27560 |
| Contact | Christy Stevens |
| Correspondent | Christy Stevens TEARSCIENCE, INC. 5151 MCCRIMMON PARKWAY SUITE 250 Morrisville, NC 27560 |
| Product Code | ORZ |
| CFR Regulation Number | 886.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-16 |
| Decision Date | 2011-12-19 |
| Summary: | summary |