K143190 is an FDA 510(k) clearance for the Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens. This device is classified as a Lens, Contact, (disposable) (Class II - Special Controls, product code MVN).
Submitted by Yung Sheng Optical Co., Ltd. (Taichung City, TW). The FDA issued a Cleared decision on January 16, 2015, 72 days after receiving the submission on November 5, 2014.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5925.
| 510(k) Number | K143190 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 05, 2014 |
| Decision Date | January 16, 2015 |
| Days to Decision | 72 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | MVN - Lens, Contact, (disposable) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.5925 |