Cleared Traditional

K143431 - Giselle (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted)

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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Eyereg Consulting, Inc.
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 486
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K143431.
BHV VIVID (etafilcon A) Soft (Hydropholic) Contact Lens
K143280 · Brien Holden Vision Pty , Ltd. · Apr 2015
EZvue UV, Soft Daily Wear Contact Lenses (ocufilcon D), EZvue Colors, Soft Daily Wear Contact Lenses (ocufilcon D)
K150293 · I-See Vision Technology, Inc. · Apr 2015
I-55 (methafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear
K142766 · INTEROJO, Inc. · Mar 2015
Bausch + Lomb Biotrue ONEday for Astigmatism(nesofilcon A) Soft (hydrophilic) Contact Lens
K143632 · Bausch & Lomb, Incorporated · Feb 2015
Intelliwave4
K142641 · Art Optical Contact Lens, Inc. · Jan 2015
Eye Secret 38 UV Aspheric Color(polymacon) Soft(hydrophilic) Contact Lens for Daily
K143052 · Yung Sheng Optical Co., Ltd. · Dec 2014