Cleared Traditional

K232649 - Pegavision (Hioxifilcon A) Daily Dispos...

K232649 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 251-day FDA review.

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

K232649 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 May 8, 2024 after a review of 251 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 - K232649

510(k) Number K232649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
141d slower than avg
Panel avg: 110d · This submission: 251d
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 K232649.
Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A)
K242059 · X-Cel Specialty Contacts, A Walman Optical Company · Aug 2024
OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™
K241707 · Unicon Optical Co., Ltd. · Jul 2024
Saview SH 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens
K240477 · St. shine Optical Co., Ltd. · Jul 2024
Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens
K240519 · Innova Vision, Inc. · Apr 2024
Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)
K233221 · Metro Optics of Austin, Inc. · Feb 2024
Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact Lens with UV Blocker
K234127 · CooperVision, Inc. · Jan 2024