K143205 is an FDA 510(k) clearance for the Viscoelastic Injector. 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 December 5, 2014, 28 days after receiving the submission on November 7, 2014.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K143205 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 07, 2014 |
| Decision Date | December 05, 2014 |
| Days to Decision | 28 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 |