K160344 is an FDA 510(k) clearance for the 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. 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 May 26, 2016, 108 days after receiving the submission on February 8, 2016.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5925.
| 510(k) Number | K160344 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 08, 2016 |
| Decision Date | May 26, 2016 |
| Days to Decision | 108 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 |