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510(k) K244009

Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear (Daily Wear); Pure Plus UV Aspheric (Otufilcon A) 1-Day Silicone Soft (hydrophilic) Contact Lens (Daily Disposable) by Yung Sheng Optical Co., Ltd. — Product Code LPL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 2025
Date Received
December 26, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lenses, Soft Contact, Daily Wear
Device Class
Class II
Regulation Number
886.5925
Review Panel
OP
Submission Type

Other clearances by Yung Sheng Optical Co., Ltd.

  • K232839 — Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon) S (December 16, 2024)
  • 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)
  • K150630 — Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily (June 15, 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)

Other clearances for product code LPL

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  • K251683 — Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Bl (December 23, 2025)
  • K250364 — Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contac (October 7, 2025)
  • K251095 — Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses (September 17, 2025)
  • K251573 — VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens (September 10, 2025)
  • K242855 — P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) (July 30, 2025)
  • K243868 — Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Peg (July 2, 2025)
  • K242056 — miacare (DELiGHT daily wear/ DELiGHT 1-day/ CONFiDENCE Color daily wear/CONFiDEN (April 17, 2025)
  • K243953 — Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color) (April 10, 2025)