The following data is part of a premarket notification filed by St. Shine Optical Co., Ltd. with the FDA for Saview-colors Aqua 42 Uv (hefilcon A) Soft (hydrophilic) Contact Lens, Saview-colors Aqua 42 Uv Toric (hefilcon A) Soft (hydrophilic) Contact Lens, Saview-colors Aqua 42 Uv Multifocal (hefilcon A) Soft (hydrophilic) Contact Lens.
| Device ID | K162317 |
| 510k Number | K162317 |
| Device Name: | Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | ST. SHINE OPTICAL CO., LTD. 4,5F NO. 276-2, SEC. 1, TA TUNG RD., HSI CHIH DIST. New Taipei City, TW 22146 |
| Contact | Ella Lee |
| Correspondent | Ella Lee ST. SHINE OPTICAL CO., LTD. 4,5F NO. 276-2, SEC. 1, TA TUNG RD., HSI CHIH DIST. New Taipei City, TW 22146 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-19 |
| Decision Date | 2016-10-21 |
| Summary: | summary |