K212631 is an FDA 510(k) clearance for the Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses. This device is classified as a Lens, Contact (other Material) - Daily (Class II - Special Controls, product code HQD).
Submitted by Contamac, Ltd. (Saffron Walden, GB). The FDA issued a Cleared decision on March 17, 2022, 210 days after receiving the submission on August 19, 2021.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5916.
| 510(k) Number | K212631 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 19, 2021 |
| Decision Date | March 17, 2022 |
| Days to Decision | 210 days |
| Submission Type | Traditional |
| 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 |