Cleared Traditional

K143431 - Giselle (polymacon) Daily Wear Soft (hy...

K143431 is an FDA 510(k) clearance for Giselle (polymacon) Daily Wear Soft (hy..., manufactured by I-Codi Co., Ltd.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K143431 · I-Codi Co., Ltd. · Ophthalmic device
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Optimized for regulatory review, auditing and printing
Feb 2015
Decision
81d
Days
Class 2
Risk

K143431 is an FDA 510(k) clearance for the Giselle (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and T.... Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by I-Codi Co., Ltd. (Buk-Gu, KR). The FDA issued a Cleared decision on February 20, 2015 after a review of 81 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 I-Codi Co., Ltd. devices

FDA 510(k) Submission Details - K143431

510(k) Number K143431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2014
Decision Date February 20, 2015
Days to Decision 81 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
29d faster than avg
Panel avg: 110d · This submission: 81d
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 170
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K143431.
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K150590 · Contamac, Ltd. · Jul 2015
Bausch + Lomb Biotrue ONEday for Astigmatism(nesofilcon A) Soft (hydrophilic) Contact Lens
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AIR OPTIX COLORS, AIR OPTIX COLORS TORIC, AIR OPTIX COLORS MULTIFOCAL
K133176 · Ciba Vision Corporation · Jan 2014
AVAIRA SPHERIC AND TORIC (ENFILCON A) SOFT CONTACT LENS
K133627 · CooperVision, Inc. · Dec 2013