The following data is part of a premarket notification filed by St. Shine Optical Co., Ltd. with the FDA for Saview-aqua 58 Uv (etafilcon A) Visibility Tinted Soft (hydrophilic) Contact Lens, Saview-aqua 58 Uv Toric (etafilcon A).
| Device ID | K132146 |
| 510k Number | K132146 |
| Device Name: | SAVIEW-AQUA 58 UV (ETAFILCON A) VISIBILITY TINTED SOFT (HYDROPHILIC) CONTACT LENS, SAVIEW-AQUA 58 UV TORIC (ETAFILCON A) |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | ST. SHINE OPTICAL CO., LTD. 4,5 F/L NO. 276-2 SEC. 1 TATUNG RD.,HSICHIN CITY Taipei Hsien, TW 221 |
| Contact | Ella Lee |
| Correspondent | Ella Lee ST. SHINE OPTICAL CO., LTD. 4,5 F/L NO. 276-2 SEC. 1 TATUNG RD.,HSICHIN CITY Taipei Hsien, 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 | 2013-07-11 |
| Decision Date | 2013-08-30 |
| Summary: | summary |