The following data is part of a premarket notification filed by Tearscience, Inc. with the FDA for Lipiview Ocular Surface Interferometer.
| Device ID | K091935 |
| 510k Number | K091935 |
| Device Name: | LIPIVIEW OCULAR SURFACE INTERFEROMETER |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | TEARSCIENCE, INC. 1101 G AVIATION PKWY Morrisville, NC 27560 |
| Contact | Christy Stevens |
| Correspondent | Christy Stevens TEARSCIENCE, INC. 1101 G AVIATION PKWY Morrisville, NC 27560 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-30 |
| Decision Date | 2009-10-23 |
| Summary: | summary |