The following data is part of a premarket notification filed by Visco Vision Inc. with the FDA for Oxysoft (olifilcon C) Silicone Hydrogel Soft Contact Lens.
| Device ID | K191397 |
| 510k Number | K191397 |
| Device Name: | OxySoft (olifilcon C) 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. 3F, No. 364, Jixian Rd., Luzhou Dist. New Taipei City, TW 24747 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-24 |
| Decision Date | 2019-10-02 |