Cleared Traditional

Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses

K232649 · Pegavision Corporation · Ophthalmic
May 2024
Decision
251d
Days
Class 2
Risk

About This 510(k) Submission

K232649 is an FDA 510(k) clearance for the Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses, a Lenses, Soft Contact, Daily Wear (Class II — Special Controls, product code LPL), submitted by Pegavision Corporation (Taoyuan City, TW). The FDA issued a Cleared decision on May 8, 2024, 251 days after receiving the submission on August 31, 2023. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K232649 FDA.gov
FDA Decision Cleared SESE
Date Received August 31, 2023
Decision Date May 08, 2024
Days to Decision 251 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code LPL — Lenses, Soft Contact, Daily Wear
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.5925

Similar Devices — LPL Lenses, Soft Contact, Daily Wear

All 480
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses
K252385 · Pegavision Corporation · Mar 2026
DAILIES TOTAL1?; DAILIES TOTAL1? Multifocal
K254052 · Alcon Laboratories, Inc. · Feb 2026
Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Presbyopia (EDOF)
K251683 · Bruno Vision Care, LLC · Dec 2025
Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens
K250364 · St. shine Optical Co., Ltd. · Oct 2025
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)
K244009 · Yung Sheng Optical Co., Ltd. · Sep 2025
Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses
K251095 · Pegavision Corporation · Sep 2025

More from Pegavision Corporation

View all
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses
K252385 · LPL · Mar 2026
Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses
K251095 · LPL · Sep 2025
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses
K243868 · LPL · Jul 2025
Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)
K222885 · LPL · May 2023
Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses
K211603 · LPL · Feb 2022