The following data is part of a premarket notification filed by The Lagado Corp. with the FDA for Tyro-97 (hofocon A), Onsi 56 (hofocon), Rigid Gas Permeable Spherical, Aspheric, Toric And Bifocal Contact Lens.
| Device ID | K102154 |
| 510k Number | K102154 |
| Device Name: | TYRO-97 (HOFOCON A), ONSI 56 (HOFOCON), RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS |
| Classification | Lens, Contact (other Material) - Daily |
| Applicant | THE LAGADO CORP. 203 NORTH WABASH, STE 2208 Chicago, IL 60601 |
| Contact | John M Szabocisk |
| Correspondent | John M Szabocisk THE LAGADO CORP. 203 NORTH WABASH, STE 2208 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 | 2010-07-30 |
| Decision Date | 2011-01-21 |
| Summary: | summary |