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510(k) K251573

VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens by Vizionfocus, Inc. — Product Code LPL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 2025
Date Received
May 22, 2025
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 Vizionfocus, Inc.

  • K243953 — Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color) (April 10, 2025)
  • K242413 — VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable (December 17, 2024)
  • K192225 — Legacy (Ocufilcon D) Performance- Tinted Soft (Hydrophilic) Daily Wear Contact L (December 9, 2019)
  • K182247 — ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color (October 12, 2018)

Other clearances for product code LPL

  • 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)
  • 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)
  • 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)