Cleared Traditional

K242413 - VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens (FDA 510(k) Clearance)

Also includes:
VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K242413 · Vizionfocus, Inc. · Ophthalmic device
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Dec 2024
Decision
125d
Days
Class 2
Risk

K242413 is an FDA 510(k) clearance for the VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposa.... Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Vizionfocus, Inc. (Miaoli County, TW). The FDA issued a Cleared decision on December 17, 2024 after a review of 125 days - within the typical 510(k) review window.

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 Vizionfocus, Inc. devices

Submission Details

510(k) Number K242413 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2024
Decision Date December 17, 2024
Days to Decision 125 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
15d slower than avg
Panel avg: 110d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Consultant

Andre Vision and Device Research
Bret Andre

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LPL Lenses, Soft Contact, Daily Wear

All 482
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K242413.
PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS
K253885 · GEO MEDICAL CO., LTD. · Apr 2026
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K254269 · St. shine Optical Co., Ltd. · Mar 2026
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses
K252385 · Pegavision Corporation · Mar 2026
DAILIES TOTAL1®
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
K250364 · St. shine Optical Co., Ltd. · Oct 2025