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— 510(k) K150630

Clearance details

Applicant

Yung Sheng Optical Co., Ltd.

Product code

Code MVN

Device class

Class 2

Regulation

21 CFR 886.5925

Advisory panel

Ophthalmic

Date received

2015-03-11

Decision date

2015-06-15

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Taichung City, TW

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• K143190 — Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens2015-01-16
• K130331 — SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER2013-07-26

• K244009 — Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear (Daily Wear) +1 more2025-09-25
• K232839 — Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear2024-12-16
• K223585 — Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear2023-12-20
• K213983 — Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear2022-09-02
• K151586 — Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens2015-08-10

Injury

149

Total

149

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →