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510(k) K241707

OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ by Unicon Optical Co., Ltd. — Product Code LPL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 2024
Date Received
June 13, 2024
Clearance Type
Special
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 Unicon Optical Co., Ltd.

  • K213216 — Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens (January 18, 2022)
  • K191929 — UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens (September 17, 2019)
  • K182734 — Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Dispo (May 16, 2019)
  • K141917 — UNICON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER FOR DAILY W (October 17, 2014)

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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)
  • K244009 — Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for (September 25, 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)