The following data is part of a premarket notification filed by Sight Sciences, Inc. with the FDA for Tearcare System.
| Device ID | K213045 |
| 510k Number | K213045 |
| Device Name: | TearCare System |
| Classification | Eyelid Thermal Pulsation System |
| Applicant | Sight Sciences, Inc. 4040 Campbell Ave., Suite 100 Menlo Park, CA 94025 |
| Contact | Edward J. Sinclair |
| Correspondent | Edward J. Sinclair Sight Sciences, Inc. 4040 Campbell Ave., Suite 100 Menlo Park, CA 94025 |
| Product Code | ORZ |
| CFR Regulation Number | 886.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-22 |
| Decision Date | 2021-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858027006495 | K213045 | 000 |
| 00858027006457 | K213045 | 000 |