Submission Details
| 510(k) Number | K143190 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens
Jan 2015
Decision
72d
Days
Class 2
Risk
About This 510(k) Submission
K143190 is an FDA 510(k) clearance for the Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens, 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 review panel. Regulated under 21 CFR 886.5925.
Device Classification
| Product Code | MVN — Lens, Contact, (disposable) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.5925 |
Manufacturer
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