Cleared Traditional

Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens (K182523) - FDA 510(k) Clearance

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

K182523 · Largan Medical Co., Ltd. · Ophthalmic device
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Nov 2018
Decision
49d
Days
Class 2
Risk

K182523 is an FDA 510(k) clearance for the Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Largan Medical Co., Ltd. (Taichung, TW). The FDA issued a Cleared decision on November 1, 2018 after a review of 49 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Largan Medical Co., Ltd. devices

Submission Details

510(k) Number K182523 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2018
Decision Date November 01, 2018
Days to Decision 49 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
61d faster than avg
Panel avg: 110d · This submission: 49d
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 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 K182523.
Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens
K182249 · Bausch & Lomb, Incorporated · Nov 2018
DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech, DAILIES AquaComfort Plus Toric and DAILIES AquaComfort Plus Multifocal
K181454 · Alcon Laboratories, Inc. · Nov 2018
Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia
K182674 · Largan Medical Co., Ltd. · Nov 2018
ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color)
K182247 · Vizionfocus, Inc. · Oct 2018
Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel Soft Contact Lens
K181349 · Visco Vision, Inc. · Sep 2018
Sofclear Enhance (methafilcon A) Daily Wear Contact Lens, Sofclear Colors (methafilcon A) Daily Wear Contact Lens, Sofclear Comfort (methafilcon A) Daily Wear Contact Lens
K181558 · Gelflex Laboratories · Sep 2018