The following data is part of a premarket notification filed by Acuity Polymers, Inc. with the FDA for 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.
| Device ID | K180988 |
| 510k Number | K180988 |
| Device Name: | 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 |
| Classification | Lens, Contact (other Material) - Daily |
| Applicant | Acuity Polymers, Inc. 1667 Lake Avenue, Suite 354 Rochester, NY 14615 |
| Contact | James A. Bonafini |
| Correspondent | James A. Bonafini Acuity Polymers, Inc. 1667 Lake Avenue, Suite 354 Rochester, NY 14615 |
| Product Code | HQD |
| CFR Regulation Number | 886.5916 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-16 |
| Decision Date | 2018-06-08 |
| Summary: | summary |