Cleared Traditional

K202129 - Largan DB / DB Color (ocufilcon D) Dail...

K202129 is an FDA 510(k) clearance for Largan DB / DB Color (ocufilcon D) Dail..., manufactured by Largan Medical Co., Ltd.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 244-day FDA review.

K202129 · Largan Medical Co., Ltd. · Ophthalmic device
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Apr 2021
Decision
244d
Days
Class 2
Risk

K202129 is an FDA 510(k) clearance for the Largan DB / DB 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 April 1, 2021 after a review of 244 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 Largan Medical Co., Ltd. devices

FDA 510(k) Submission Details - K202129

510(k) Number K202129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2020
Decision Date April 01, 2021
Days to Decision 244 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
134d slower than avg
Panel avg: 110d · This submission: 244d
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 K202129.
Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia
K210975 · Bausch & Lomb, Incorporated · May 2021
AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens
K210609 · Vp Optics · Apr 2021
Total30, Total30 for Astigmatism, Total30 Multifocal, Total30 Multifocal Toric, Total30 Asphere
K210436 · Alcon Laboratories, Inc. · Apr 2021
HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens
K200618 · Visco Vision, Inc. · Dec 2020
Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)
K201268 · Plexus Optix, Inc. · Oct 2020
Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day Multifocal (somofilcon A), Clariti 1 Day Multifocal Toric (somofilcon A)
K202756 · CooperVision, Inc. · Oct 2020