The following data is part of a premarket notification filed by Yung Sheng Optical Co., Ltd with the FDA for Eye Secret 59 Uv Aspheric (omafilcon A) Soft (hydrophilic) Contact Lens For Daily Wear.
| Device ID | K213983 |
| 510k Number | K213983 |
| Device Name: | Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens For Daily Wear |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | Yung Sheng Optical Co., Ltd No. 8, Keya 2nd Road, Daya District Taichung City, TW 428 |
| Contact | Wen-Han Chen |
| Correspondent | Wen-Han Chen Yung Sheng Optical Co., Ltd No. 8, Keya 2nd Road, Daya District Taichung City, TW 428 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-20 |
| Decision Date | 2022-09-02 |