Cleared Traditional

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

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.