The following data is part of a premarket notification filed by Optical Systems Intl., Inc. with the FDA for The Ultra-mate Lens.
| Device ID | K854218 |
| 510k Number | K854218 |
| Device Name: | THE ULTRA-MATE LENS |
| Classification | Lens, Spectacle, Non-custom (prescription) |
| Applicant | OPTICAL SYSTEMS INTL., INC. 1652 W. 32ND. PLACE Hialeah, FL 33012 |
| Contact | De Rojas |
| Correspondent | De Rojas OPTICAL SYSTEMS INTL., INC. 1652 W. 32ND. PLACE Hialeah, FL 33012 |
| Product Code | HQG |
| CFR Regulation Number | 886.5844 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-17 |
| Decision Date | 1985-11-12 |