The following data is part of a premarket notification filed by Tearscience, Inc. with the FDA for Lipiscan Dynamic Meibomian Imager.
| Device ID | K182506 |
| 510k Number | K182506 |
| Device Name: | LipiScan Dynamic Meibomian Imager |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | TearScience, Inc. 5151 McCrimmon Pkwy. Ste. 250 Morrisville, NC 27560 |
| Contact | Christy Coleman |
| Correspondent | Christy Coleman TearScience, Inc. 5151 McCrimmon Pkwy. Ste. 250 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 | 2018-09-12 |
| Decision Date | 2018-12-10 |
| Summary: | summary |