FDA 510(k) Applications Submitted by James A. Bonafini
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K213538 |
11/08/2021 |
Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens |
Acuity Polymers, Inc. |
| K163254 |
11/21/2016 |
Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens |
Acuity Polymers, Inc. |
| K170007 |
01/03/2017 |
Acuity 58 (Enflufocon B) Rigid Gas Permeable Contact Lens |
Acuity Polymers, Inc. |
| K180988 |
04/16/2018 |
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 |
Acuity Polymers, Inc. |
| K201194 |
05/04/2020 |
Acuity 200Ö (fluoroxyfocon A) Rigid Gas Permeable Contact Lens |
Acuity Polymers, Inc. |
| K162005 |
07/20/2016 |
Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens |
Acuity Polymers, Inc. |
| K203571 |
12/07/2020 |
Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens |
Acuity Polymers, Inc. |
| K170001 |
01/03/2017 |
Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens |
Acuity Polymers, Inc. |
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