The following data is part of a premarket notification filed by Menicon Co., Ltd. with the FDA for Miru 1day Upside (midafilcon A).
| Device ID | K193399 |
| 510k Number | K193399 |
| Device Name: | Miru 1day UpSide (midafilcon A) |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | Menicon Co., Ltd. 21-19, Aoi 3, Naka-ku Nagoya, JP 460-0006 |
| Contact | Li Haosheng |
| Correspondent | Li Haosheng Menicon Co., Ltd. 21-19, Aoi 3, Naka-ku Nagoya, JP 460-0006 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-06 |
| Decision Date | 2020-06-17 |