The following data is part of a premarket notification filed by Visionary Technologies Of Miami, Inc. with the FDA for Virectomy Lens.
| Device ID | K940107 |
| 510k Number | K940107 |
| Device Name: | VIRECTOMY LENS |
| Classification | Lens, Contact, Polymethylmethacrylate, Diagnostic |
| Applicant | VISIONARY TECHNOLOGIES OF MIAMI, INC. 8306 MILLS DRIVE, SUITE 147 Miami, FL 33183 |
| Contact | Thomas Mestrits |
| Correspondent | Thomas Mestrits VISIONARY TECHNOLOGIES OF MIAMI, INC. 8306 MILLS DRIVE, SUITE 147 Miami, FL 33183 |
| Product Code | HJK |
| CFR Regulation Number | 886.1385 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-10 |
| Decision Date | 1994-09-06 |