K203569 is an FDA 510(k) clearance for the Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants. This device is classified as a Weights, Eyelid, Implantable (Class II - Special Controls, product code NCB).
Submitted by Fci (France Chirurgie Instrumentation) Sas (Paris, FR). The FDA issued a Cleared decision on June 11, 2021, 186 days after receiving the submission on December 7, 2020.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5700. Gravity Assisted Treatment Of Lagophthalmos (incomplete Eyelid Closure).
| 510(k) Number | K203569 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 07, 2020 |
| Decision Date | June 11, 2021 |
| Days to Decision | 186 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | NCB - Weights, Eyelid, Implantable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.5700 |
| Definition | Gravity Assisted Treatment Of Lagophthalmos (incomplete Eyelid Closure) |