K182734 is an FDA 510(k) clearance for the Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contac. This device is classified as a Lenses, Soft Contact, Daily Wear (Class II - Special Controls, product code LPL).
Submitted by Unicon Optical Co., Ltd. (Hsinchu County, TW). The FDA issued a Cleared decision on May 16, 2019, 230 days after receiving the submission on September 28, 2018.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5925.
| 510(k) Number | K182734 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 2018 |
| Decision Date | May 16, 2019 |
| Days to Decision | 230 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 |