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, Eye Secret 55 Uv Aspheric ( Methafilcon A) Soft (hydrophilic) Contact Lens For Daily Wear.
| Device ID | K150630 |
| 510k Number | K150630 |
| Device Name: | Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens For Daily Wear, Eye Secret 55 UV Aspheric ( Methafilcon A) Soft (hydrophilic) Contact Lens For Daily Wear |
| Classification | Lens, Contact, (disposable) |
| 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 | MVN |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-11 |
| Decision Date | 2015-06-15 |
| Summary: | summary |