The following data is part of a premarket notification filed by Acuity Polymers, Inc. with the FDA for Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens.
| Device ID | K203571 |
| 510k Number | K203571 |
| Device Name: | Acuity 200 (fluoroxyfocon 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 | Bret Andre EyeReg Consulting Inc. 6119 Canter Lane West Linn, OR 97068 |
| Product Code | HQD |
| CFR Regulation Number | 886.5916 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-07 |
| Decision Date | 2021-04-09 |