The following data is part of a premarket notification filed by Yung Sheng Optical Co., Ltd. with the FDA for Eye Secret 55 Uv Aspheric (methafilcon A) Soft (hydrophilic) Contact Lens.
Device ID | K151586 |
510k Number | K151586 |
Device Name: | Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens |
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 | 2015-06-11 |
Decision Date | 2015-08-10 |
Summary: | summary |