Cleared Traditional

Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color) (K243953) - FDA 510(k) Clearance

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

K243953 · Vizionfocus, Inc. · Ophthalmic device
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Apr 2025
Decision
108d
Days
Class 2
Risk

K243953 is an FDA 510(k) clearance for the Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color). 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 April 10, 2025 after a review of 108 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 K243953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2024
Decision Date April 10, 2025
Days to Decision 108 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
2d faster than avg
Panel avg: 110d · This submission: 108d
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 99
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K243953.
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
miacare (DELiGHT daily wear/ DELiGHT 1-day/ CONFiDENCE Color daily wear/CONFiDENCE Color 1-day) Contact Lens with EautraSil Plus
K242056 · Benq Materials Corporation · Apr 2025
HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens (HPM38)
K241884 · Hunan Haipuming Technology Co., Ltd. · Mar 2025
Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens
K242916 · Largan Medical Co., Ltd. · Feb 2025
Precision1
K243909 · Alcon Laboratories, Inc. · Jan 2025