The following data is part of a premarket notification filed by Visco Vision Inc with the FDA for Si-hy (olifilcon B) Sperical Silicone Hydrogel Soft Contact Lens, Si-hy (olifilcon B) Multifocal Silicone Hydrogel Soft Contact Lenses, Si-hy (olifilcon B) Toric Silicone Hydrogel Soft Contact Lens2/16/2016.
| Device ID | K160344 |
| 510k Number | K160344 |
| Device Name: | Si-Hy (olifilcon B) Sperical Silicone Hydrogel Soft Contact Lens, Si-Hy (olifilcon B) Multifocal Silicone Hydrogel Soft Contact Lenses, Si-Hy (olifilcon B) Toric Silicone Hydrogel Soft Contact Lens2/16/2016 |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | Visco Vision Inc No. 1, Xingye St., Guishan Dist., Taoyuan, TW 33341 |
| Contact | Evan Huang |
| Correspondent | Jennifer Ting Jens Medical Consulting Ltd. 6F. No. 39, Jixian Rd, Luzhou Dist. New Taipei City, TW 247 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-08 |
| Decision Date | 2016-05-26 |
| Summary: | summary |