Submission Details
| 510(k) Number | K242393 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 13, 2024 |
| Decision Date | November 01, 2024 |
| Days to Decision | 80 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Traditional
Acuity 181? (tisilfocon A) and Acuity 181? (tisilfocon A) with Tangible? Hydra-PEG? Rigid Gas Permeable Contact Lenses
Nov 2024
Decision
80d
Days
Class 2
Risk
About This 510(k) Submission
K242393 is an FDA 510(k) clearance for the Acuity 181? (tisilfocon A) and Acuity 181? (tisilfocon A) with Tangible? Hydra-PEG? Rigid Gas Permeable Contact Lenses, 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 November 1, 2024, 80 days after receiving the submission on August 13, 2024. 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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