The following data is part of a premarket notification filed by St. Shine Optical Co., Ltd. with the FDA for Savie-aqua 55uv (methafilcon A) Tinnted Blue Soft (hydrophilic) Contact Lens.
| Device ID | K121201 |
| 510k Number | K121201 |
| Device Name: | SAVIE-AQUA 55UV (METHAFILCON A) TINNTED BLUE SOFT (HYDROPHILIC) CONTACT LENS |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | ST. SHINE OPTICAL CO., LTD. 4,5 F/L NO. 276-2 SEC. 1 TATUNG RD.,HSI CHIN DIST New Taipei City, TW 221 |
| Contact | Ella Lee |
| Correspondent | Ella Lee ST. SHINE OPTICAL CO., LTD. 4,5 F/L NO. 276-2 SEC. 1 TATUNG RD.,HSI CHIN DIST New Taipei City, TW 221 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-19 |
| Decision Date | 2012-10-26 |
| Summary: | summary |