Submission Details
| 510(k) Number | K201194 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 04, 2020 |
| Decision Date | September 08, 2020 |
| Days to Decision | 127 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Traditional
Acuity 200? (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
Sep 2020
Decision
127d
Days
Class 2
Risk
About This 510(k) Submission
K201194 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 September 8, 2020, 127 days after receiving the submission on May 4, 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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