The following data is part of a premarket notification filed by Visco Vision Inc with the FDA for Vexillum Zephyr (olifilcon A) With Tangible Polymers Spherical/toric/multifocal Silicone Hydrogel Soft Contact Lens ; Oxypure A (olifilcon A) Spherical/toric/multifocal Silicone Hydrogel Soft Contact Lens.
| Device ID | K183670 |
| 510k Number | K183670 |
| Device Name: | Vexillum Zephyr (olifilcon A) With Tangible Polymers Spherical/Toric/Multifocal Silicone Hydrogel Soft Contact Lens ; OxyPure A (olifilcon A) Spherical/Toric/Multifocal Silicone Hydrogel Soft Contact Lens |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | Visco Vision Inc No. 1, Xingye St., Guishan Dist., Taoyuan City, TW 33341 |
| Contact | Evan Huang |
| Correspondent | Evan Huang Visco Vision Inc No. 1, Xingye St., Guishan Dist., Taoyuan City, TW 33341 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-27 |
| Decision Date | 2019-09-13 |
| Summary: | summary |