The following data is part of a premarket notification filed by Visco Vision Inc with the FDA for Oxyaqua (olifilcon D) Spherical Silicone Hydrogel Soft Contact Lens, Oxyaqua (olifilcon D) Multifocal Silicone Hydrogel Soft Contact Lens, Oxyaqua (olifilcon D) Toric Silicone Hydrogel Soft Contact Lens.
| Device ID | K173958 |
| 510k Number | K173958 |
| Device Name: | OxyAqua (olifilcon D) Spherical Silicone Hydrogel Soft Contact Lens, OxyAqua (olifilcon D) Multifocal Silicone Hydrogel Soft Contact Lens, OxyAqua (olifilcon D) Toric Silicone Hydrogel Soft Contact Lens |
| 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 | 2017-12-28 |
| Decision Date | 2018-04-03 |
| Summary: | summary |