K213045 is an FDA 510(k) clearance for the TearCare System. This device is classified as a Eyelid Thermal Pulsation System (Class II - Special Controls, product code ORZ).
Submitted by Sight Sciences, Inc. (Menlo Park, US). The FDA issued a Cleared decision on December 21, 2021, 90 days after receiving the submission on September 22, 2021.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5200. Therapeutic Application Of Heat And Massage To The Eyelids..
| 510(k) Number | K213045 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 22, 2021 |
| Decision Date | December 21, 2021 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | ORZ - Eyelid Thermal Pulsation System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.5200 |
| Definition | Therapeutic Application Of Heat And Massage To The Eyelids. |