The following data is part of a premarket notification filed by Yung Sheng Optical Co., Ltd. with the FDA for Eye Secret 38 Uv Aspheric (polymacon) Soft (hydrophilic) Contact Lens For Daily Wear.
| Device ID | K132854 |
| 510k Number | K132854 |
| Device Name: | EYE SECRET 38 UV ASPHERIC (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | YUNG SHENG OPTICAL CO., LTD. 3F-1, NO. 6, JHONGKE ROAD, DAYA DISTRICT Taichung City, TW 42881 |
| Contact | Wen-han Chen |
| Correspondent | Wen-han Chen YUNG SHENG OPTICAL CO., LTD. 3F-1, NO. 6, JHONGKE ROAD, DAYA DISTRICT Taichung City, TW 42881 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-12 |
| Decision Date | 2013-12-23 |
| Summary: | summary |