K213880 is an FDA 510(k) clearance for the Custom Stable Rigid Gas Permeable Scleral Contact Lens. This device is classified as a Lens, Contact (other Material) - Daily (Class II - Special Controls, product code HQD).
Submitted by Valley Contax, Inc. (Springfield, US). The FDA issued a Cleared decision on January 7, 2022, 25 days after receiving the submission on December 13, 2021.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5916.
| 510(k) Number | K213880 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 13, 2021 |
| Decision Date | January 07, 2022 |
| Days to Decision | 25 days |
| Submission Type | Special |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HQD - Lens, Contact (other Material) - Daily |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.5916 |