Cleared Traditional

K020855 - IGEL 55UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IGEL 55 UV MULTIFOCAL (METHAFILCON A) SOFT

K020855 is an FDA 510(k) clearance for IGEL 55UV (METHAFILCON A) SOFT (HYDROPH..., manufactured by Igel Vision Care Pte , 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.

K020855 · Igel Vision Care Pte , Ltd. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2002
Decision
81d
Days
Class 2
Risk

K020855 is an FDA 510(k) clearance for the IGEL 55UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IGEL.... Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Igel Vision Care Pte , Ltd. (Tracy, US). The FDA issued a Cleared decision on June 4, 2002 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 - K020855

510(k) Number K020855 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2002
Decision Date June 04, 2002
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 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 K020855.
HORIZON 38 (CLEAR) AND HORIZON 38 WESTINT (TINTED)
K023530 · Westcon Contact Lens Co., Inc. · Nov 2002
IGEL 55 TORIC (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
K021907 · Igel Vision Care Pte , Ltd. · Sep 2002
MULTIVISION METHAFILCON A SOFT (HYDROPILIC) MULTIFOCAL LENS FOR DAILY WEAR
K021720 · Soflex Isralens Contact Lens , Ltd. · Aug 2002
SAVIEW TORIC 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR
K021295 · St. shine Optical Co., Ltd. · Jun 2002
SOFT K. AND SOFT K. TORIC (XYLOFICON A) SOFT (HYDROPHILLIC) KERATOCONUS CONTACT LENS FOR DAILY WEAR
K020642 · Soflex Contact Lens Industries , Ltd. · May 2002
HD/HDT, (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY CAST-MOLDED LENS)
K020608 · Poly Vue Technolgies, Inc. · May 2002
K020855 · IGEL 55UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IGEL 55 UV MULTIFOCAL (METHAFILCON A) SOFT
Download PDF FDA Summary Igel Vision Care Pte …