K212741 is an FDA 510(k) clearance for the EZYPOR. This device is classified as a Implant, Eye Sphere (Class II - Special Controls, product code HPZ).
Submitted by Fci (France Chirurgie Instrumentation) Sas (Paris, FR). The FDA issued a Cleared decision on June 24, 2022, 298 days after receiving the submission on August 30, 2021.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.3320.
| 510(k) Number | K212741 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 30, 2021 |
| Decision Date | June 24, 2022 |
| Days to Decision | 298 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HPZ - Implant, Eye Sphere |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.3320 |