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510(k) K150630

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 by Yung Sheng Optical Co., Ltd. — Product Code MVN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 2015
Date Received
March 11, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lens, Contact, (Disposable)
Device Class
Class II
Regulation Number
886.5925
Review Panel
OP
Submission Type

Other clearances by Yung Sheng Optical Co., Ltd.

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  • K223585 — Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for (December 20, 2023)
  • K213983 — Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens for Dail (September 2, 2022)
  • K151586 — Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens (August 10, 2015)
  • K143190 — Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens (January 16, 2015)
  • K143052 — Eye Secret 38 UV Aspheric Color(polymacon) Soft(hydrophilic) Contact Lens for Da (December 16, 2014)
  • K133735 — EYE SECRET 55 UV ASPHERIC (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS (March 21, 2014)
  • K132854 — EYE SECRET 38 UV ASPHERIC (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY (December 23, 2013)

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  • K061157 — SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS (June 22, 2006)