The following data is part of a premarket notification filed by Optixon Inc. with the FDA for Optixon 1-day.
| Device ID | K201013 |
| 510k Number | K201013 |
| Device Name: | Optixon 1-Day |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | Optixon Inc. 105/106 Ho, 164, Obong-ro, Buk-Gu Daegu, KR 41500 |
| Contact | Oh Jeong Ju |
| Correspondent | Eunbae Cho IGC Co., Ltd. Rm. 501, Daeryung Techno Town 7th, #638, Seobusaet-gil, Geumcheon-gu Seoul, KR 08504 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-17 |
| Decision Date | 2020-09-18 |