Home / 510(k) Clearances / K244009

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

K244009 is an FDA 510(k) premarket notification submitted by Yung Sheng Optical Co., Ltd. for the device "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)". The FDA issued a decision of Substantially Equivalent on September 25, 2025. The device falls under product code LPL (Lenses, Soft Contact, Daily Wear), a Class II device regulated under 21 CFR 886.5925. Yung Sheng Optical Co., Ltd. has at least 9 other 510(k) clearances on record.

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

  • K260507 — Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with (May 29, 2026)
  • K253352 — Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegav (May 21, 2026)
  • K261299 — Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Peg (May 19, 2026)
  • K253885 — PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS; PU (April 29, 2026)
  • K254269 — Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contac (March 19, 2026)
  • K252385 — Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Peg (March 13, 2026)
  • K254052 — DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal (February 13, 2026)
  • 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)

FDA data resources