Cleared Traditional

K251095 - Pegavision (Hioxifilcon A) Daily Dispos...

K251095 is an FDA 510(k) clearance for Pegavision (Hioxifilcon A) Daily Dispos..., manufactured by Pegavision Corporation. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K251095 · Pegavision Corporation · Ophthalmic device
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Sep 2025
Decision
160d
Days
Class 2
Risk

K251095 is an FDA 510(k) clearance for the Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Pegavision Corporation (Taoyuan City, TW). The FDA issued a Cleared decision on September 17, 2025 after a review of 160 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5925 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Pegavision Corporation devices

FDA 510(k) Submission Details - K251095

510(k) Number K251095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2025
Decision Date September 17, 2025
Days to Decision 160 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 110d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LPL Device Classification - Class 2, Special Controls

Product Code LPL Lenses, Soft Contact, Daily Wear
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5925
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - LPL Lenses, Soft Contact, Daily Wear

All 164
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K251095.
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
K250364 · St. shine Optical Co., Ltd. · Oct 2025
Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear (Daily Wear)
K244009 · Yung Sheng Optical Co., Ltd. · Sep 2025
VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens
K251573 · Vizionfocus, Inc. · Sep 2025
P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)
K242855 · E.O.S Co., Ltd. · Jul 2025
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses
K243868 · Pegavision Corporation · Jul 2025