Cleared Traditional

K984523 - IGEL 56 UV (HEFILCON C) SOFT (HYDROPHILIC) CONTACT LENS

K984523 is an FDA 510(k) clearance for IGEL 56 UV (HEFILCON C) SOFT (HYDROPHIL..., 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 57-day FDA review.

K984523 · Igel Vision Care Pte , Ltd. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
57d
Days
Class 2
Risk

K984523 is an FDA 510(k) clearance for the IGEL 56 UV (HEFILCON C) SOFT (HYDROPHILIC) CONTACT LENS. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Igel Vision Care Pte , Ltd. (Chicago, US). The FDA issued a Cleared decision on February 16, 1999 after a review of 57 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 Igel Vision Care Pte , Ltd. devices

FDA 510(k) Submission Details - K984523

510(k) Number K984523 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1998
Decision Date February 16, 1999
Days to Decision 57 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
53d faster than avg
Panel avg: 110d · This submission: 57d
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 279
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K984523.
RESOLUTION 45 (SPHERICAL) AND ULTRA GEL (TORIC) (HIOXIFILCON B) SOFT DAILY WEAR CONTACT LENS, )CLEAR & BLUE VISIBILITY T
K983496 · Opti-Centre Laboratories · Mar 1999
TETRAFILCON A
K990606 · CooperVision, Inc. · Mar 1999
ACTITORIC (OCUFILCON A) SOFT (HYDROPHILIC) TORIC CONTACT LENS FOR DAILY WEAR
K983160 · Hydron , Ltd. · Feb 1999
BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTACT LENS
K982947 · Ocular Sciences Puerto Rico, Inc. · Jan 1999
VISTAKON (LENEFILCON A)CONTACT LENS CLEAR AND VISIBILITY TINT WITH UV BLOCKER
K983912 · Vistakon, Johnson & Johnson Vision Products, Inc. · Jan 1999
BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTAC LENS
K984046 · Ocular Sciences Puerto Rico, Inc. · Jan 1999