K180988 is an FDA 510(k) clearance for the Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, Acuity 58 (enflufocon B) Rigid Gas Permeable Contact Lens, Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens, Acuity 100 (hexafocon A) 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 8, 2018, 53 days after receiving the submission on April 16, 2018.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5916.
| 510(k) Number | K180988 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 16, 2018 |
| Decision Date | June 08, 2018 |
| Days to Decision | 53 days |
| Submission Type | Abbreviated |
| 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 |