K232214 is an FDA 510(k) clearance for the OMNI Surgical System. This device is classified as a Pump, Infusion, Ophthalmic (Class II - Special Controls, product code MRH).
Submitted by Sight Sciences, Inc. (Menlo Park, US). The FDA issued a Cleared decision on August 25, 2023, 30 days after receiving the submission on July 26, 2023.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K232214 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 26, 2023 |
| Decision Date | August 25, 2023 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | MRH - Pump, Infusion, Ophthalmic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |