Submission Details
| 510(k) Number | K230965 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
Acuity 100? (hexafocon A) with Tangible? Hydra-PEG?, TYRO?-97 (hofocon A) with Tangible? Hydra-PEG? Rigid Gas Permeable Contact Lens
Jun 2023
Decision
72d
Days
Class 2
Risk
About This 510(k) Submission
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, 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 review panel. Regulated under 21 CFR 886.5916.
Device Classification
| Product Code | HQD — Lens, Contact (other Material) - Daily |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.5916 |
Manufacturer
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