The following data is part of a premarket notification filed by St. Shine Optical Co., Ltd. with the FDA for Saview 58 Uv; Toric & Multifocal (etafilcon A) Soft (hydrophilic) Contact Lens For Daily Wear.
| Device ID | K092852 |
| 510k Number | K092852 |
| Device Name: | SAVIEW 58 UV; TORIC & MULTIFOCAL (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR |
| 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 | Brian Lai |
| Correspondent | Brian Lai 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 | 2009-09-16 |
| Decision Date | 2010-03-11 |
| Summary: | summary |