K231084 is an FDA 510(k) clearance for the TearCare MGX 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 27, 2023, 254 days after receiving the submission on April 17, 2023.
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 | K231084 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 17, 2023 |
| Decision Date | December 27, 2023 |
| Days to Decision | 254 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. |