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.
| Device ID | K163254 |
| 510k Number | K163254 |
| Device Name: | Acuity 18 (enflufocon 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-21 |
| Decision Date | 2017-01-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850203008019 | K163254 | 000 |