K230965 is an FDA 510(k) clearance for the Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lens. This device is classified as a Lens, Contact (other Material) - Daily (Class II - Special Controls, product code HQD).
Submitted by Acuity Polymers, Inc. (Rochester, US). The FDA issued a Cleared decision on June 16, 2023, 72 days after receiving the submission on April 5, 2023.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5916.
| 510(k) Number | K230965 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 05, 2023 |
| Decision Date | June 16, 2023 |
| Days to Decision | 72 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 |