The following data is part of a premarket notification filed by Tearscience, Inc. with the FDA for Lipiview Ii Ocular Surface Interferometer.
| Device ID | K152869 |
| 510k Number | K152869 |
| Device Name: | LipiView II Ocular Surface Interferometer |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | TEARSCIENCE, INC. 5151 MCCRIMMON PKWY., STE 250 Morrisville, NC 27650 |
| Contact | Christy Coleman |
| Correspondent | Christy Coleman TEARSCIENCE, INC. 5151 MCCRIMMON PKWY., STE 250 Morrisville, NC 27650 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-30 |
| Decision Date | 2016-01-14 |
| Summary: | summary |