Submission Details
| 510(k) Number | K203571 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 07, 2020 |
| Decision Date | April 09, 2021 |
| Days to Decision | 123 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Traditional
Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
Apr 2021
Decision
123d
Days
Class 2
Risk
About This 510(k) Submission
K203571 is an FDA 510(k) clearance for the Acuity 200 (fluoroxyfocon A) 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 April 9, 2021, 123 days after receiving the submission on December 7, 2020. 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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