Eye Secret 38 UV Aspheric Color(polymacon) Soft(hydrophilic) Contact Lens for Daily +1 more— 510(k) K143052

Substantially Equivalent

Yung Sheng Optical Co., Ltd.

FDA 510(k) clearance K143052 for Eye Secret 38 UV Aspheric Color(polymacon) Soft(hydrophilic) Contact Lens for Daily +1 more, Substantially Equivalent on 2014-12-16. Applicant: Yung Sheng Optical Co., Ltd.. Device class: 2.

Clearance details

Device name as filed
Eye Secret 38 UV Aspheric Color(polymacon) Soft(hydrophilic) Contact Lens for Daily;Eye Secret 38 UV Aspheric Color(polymacon) 1-Day Soft(hydrophilic) Contact Lens
Applicant
Yung Sheng Optical Co., Ltd.
Product code
Product code LPL
Device class
Class 2
Regulation
21 CFR 886.5925
Advisory panel
Ophthalmic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Taichung City, TW
Download summary PDFView on FDA.gov ↗

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Adverse events under product code LPL

product code LPL
Injury
988
Other
4
Total
992

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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