The following data is part of a premarket notification filed by American Optical Corp. with the FDA for Duralite Lens.
| Device ID | K800192 |
| 510k Number | K800192 |
| Device Name: | DURALITE LENS |
| Classification | Lens, Contact (polymethylmethacrylate) |
| Applicant | AMERICAN OPTICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HPX |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-01-29 |
| Decision Date | 1980-03-12 |