The following data is part of a premarket notification filed by The Lagado Corp. with the FDA for Tyro 97 (hofocon A) Rigid Gas Permeable Spherical, Aspheric, Toric And Bifocal Contact Lenses For Daily Wear.
| Device ID | K052507 |
| 510k Number | K052507 |
| Device Name: | TYRO 97 (HOFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENSES FOR DAILY WEAR |
| Classification | Lens, Contact (other Material) - Daily |
| Applicant | THE LAGADO CORP. 203 NORTH WABASH AVENUE SUITE 1200 Chicago, IL 60601 |
| Contact | John M Szabocsik |
| Correspondent | John M Szabocsik THE LAGADO CORP. 203 NORTH WABASH AVENUE SUITE 1200 Chicago, IL 60601 |
| Product Code | HQD |
| CFR Regulation Number | 886.5916 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-13 |
| Decision Date | 2005-11-02 |
| Summary: | summary |