K191397 is an FDA 510(k) clearance for the OxySoft (olifilcon C) silicone hydrogel soft contact lens. This device is classified as a Lenses, Soft Contact, Daily Wear (Class II - Special Controls, product code LPL).
Submitted by Visco Vision, Inc. (Taoyuan City, TW). The FDA issued a Cleared decision on October 2, 2019, 131 days after receiving the submission on May 24, 2019.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5925.
| 510(k) Number | K191397 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 24, 2019 |
| Decision Date | October 02, 2019 |
| Days to Decision | 131 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | LPL - Lenses, Soft Contact, Daily Wear |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.5925 |