The following data is part of a premarket notification filed by St. Shine Optical Co., Ltd. with the FDA for Saview Toric 55 (methafilcon A) Soft (hydrophilic) Contact Lenses For Daily Wear.
| Device ID | K021295 |
| 510k Number | K021295 |
| Device Name: | SAVIEW TORIC 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | ST. SHINE OPTICAL CO., LTD. 13 RED FOX LN. Littleton, CO 80127 |
| Contact | Kevin Walls |
| Correspondent | Kevin Walls ST. SHINE OPTICAL CO., LTD. 13 RED FOX LN. Littleton, CO 80127 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-24 |
| Decision Date | 2002-06-04 |