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510(k) K261299

Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses by Pegavision Corporation — Product Code LPL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 2026
Date Received
April 20, 2026
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 Pegavision Corporation

  • K253352 — Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegav (May 21, 2026)
  • K252385 — Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Peg (March 13, 2026)
  • K251095 — Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses (September 17, 2025)
  • K243868 — Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Peg (July 2, 2025)
  • K232649 — Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses (May 8, 2024)
  • K222885 — Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) (May 31, 2023)
  • K211603 — Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquama (February 2, 2022)
  • K211448 — Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquama (December 6, 2021)
  • K200296 — Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lense (October 15, 2020)
  • K161739 — Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Sof (December 19, 2016)

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)
  • 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)
  • 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)