The following data is part of a premarket notification filed by Optek Medico Co., Ltd. with the FDA for Tria Lens Set.
| Device ID | K843095 |
| 510k Number | K843095 |
| Device Name: | TRIA LENS SET |
| Classification | Set, Lens, Trial, Ophthalmic |
| Applicant | OPTEK MEDICO CO., LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HPC |
| CFR Regulation Number | 886.1405 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-07 |
| Decision Date | 1984-10-05 |