K221768 is an FDA 510(k) clearance for the Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses. This device is classified as a Lens, Contact (other Material) - Daily (Class II - Special Controls, product code HQD).
Submitted by Paragon Vision Sciences, Inc. (Gilbert, US). The FDA issued a Cleared decision on May 5, 2023, 322 days after receiving the submission on June 17, 2022.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5916.
| 510(k) Number | K221768 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 17, 2022 |
| Decision Date | May 05, 2023 |
| Days to Decision | 322 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 |