Cleared Traditional

K043540 - HORIZON 59 OASIS (HIOXIFILCON A) DAILY WEAR CONTACT LENSES

K043540 is an FDA 510(k) clearance for HORIZON 59 OASIS (HIOXIFILCON A) DAILY ..., manufactured by Westcon Contact Lens Co., Inc.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K043540 · Westcon Contact Lens Co., Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
41d
Days
Class 2
Risk

K043540 is an FDA 510(k) clearance for the HORIZON 59 OASIS (HIOXIFILCON A) DAILY WEAR CONTACT LENSES. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Westcon Contact Lens Co., Inc. (Grnad Junction, US). The FDA issued a Cleared decision on February 1, 2005 after a review of 41 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 - K043540

510(k) Number K043540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2004
Decision Date February 01, 2005
Days to Decision 41 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
69d faster than avg
Panel avg: 110d · This submission: 41d
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 K043540.
MAXSIGHT (POLYMACON) SPORT-TINTED CONTACT LENS
K050157 · Bausch & Lomb, Inc. · Apr 2005
AQUAFLEX 2 (TEFILCON) CONTACT LENS
K050743 · Unilens Corp., USA · Apr 2005
59% EXTREME H2O (HIOXIFILCON A) SOFT CONTACT LENS
K040303 · Hydrogel Vision Corporation · Feb 2005
PROCLEAR ULTRAVUE MULTIFOCAL AND PROCLEAR ULTRAVUE 2000T MULTIFOCAL TORIC (OMAFLICON A) SOFT (HYDROPHILIC CONTACT LENS)
K043129 · Opti-Centre Laboratories · Jan 2005
FREQUENCY 38 AND SILVER 07 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS
K042824 · CooperVision, Inc. · Nov 2004
VISTAKON (SENOFILCON A) SOFT CONTACT LENS
K042275 · Vistakon · Oct 2004
K043540 · HORIZON 59 OASIS (HIOXIFILCON A) DAILY WEAR CONTACT LENSES
Download PDF FDA Summary Westcon Contact Lens …