K150630 is an FDA 510(k) clearance for the Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear, Eye Secret 55 UV Aspheric ( methafilcon A) Soft (hydrophilic) Contact lens for Daily Wear. 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 June 15, 2015, 96 days after receiving the submission on March 11, 2015.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5925.
| 510(k) Number | K150630 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 11, 2015 |
| Decision Date | June 15, 2015 |
| Days to Decision | 96 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 |