Submission Details
| 510(k) Number | K150630 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
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
Jun 2015
Decision
96d
Days
Class 2
Risk
About This 510(k) Submission
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, 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 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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