The following data is part of a premarket notification filed by Visionary Optics Llc with the FDA for Visionary Optics Scleral Contact Lens (roflufocon D, Roflufocon E, Hexafocon A, Hexafocon B, Tisilfocon A).
| Device ID | K223394 |
| 510k Number | K223394 |
| Device Name: | Visionary Optics Scleral Contact Lens (roflufocon D, Roflufocon E, Hexafocon A, Hexafocon B, Tisilfocon A) |
| Classification | Lens, Contact (other Material) - Daily |
| Applicant | Visionary Optics LLC 1325 Progress Drive Front Royal, VA 22630 |
| Contact | Donald R. Sanders |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-11-08 |
| Decision Date | 2022-12-07 |