The following data is part of a premarket notification filed by Acuity Polymers, Inc. with the FDA for Acuity 200 With Tangible Hydra-peg (fluoroxyfocon A) Rigid Gas Permeable Contact Lens.
| Device ID | K213538 |
| 510k Number | K213538 |
| Device Name: | Acuity 200 With Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens |
| Classification | Lens, Contact (other Material) - Daily |
| Applicant | Acuity Polymers, Inc. 1667 Lake Ave. Suite 303 Rochester, NY 14615 |
| Contact | James A Bonafini |
| Correspondent | James A Bonafini Acuity Polymers, Inc. 1667 Lake Ave. Suite 303 Rochester, NY 14615 |
| Product Code | HQD |
| CFR Regulation Number | 886.5916 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-08 |
| Decision Date | 2021-12-30 |