Cleared Traditional

K080686 - WESTCON HORIZON 49% (HIOXIFILCON B)

K080686 is an FDA 510(k) clearance for WESTCON HORIZON 49% (HIOXIFILCON B), manufactured by Westcon Contact Lens Co.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K080686 · Westcon Contact Lens Co. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
42d
Days
Class 2
Risk

K080686 is an FDA 510(k) clearance for the WESTCON HORIZON 49% (HIOXIFILCON B). Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Westcon Contact Lens Co. (Erie, US). The FDA issued a Cleared decision on April 22, 2008 after a review of 42 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 - K080686

510(k) Number K080686 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2008
Decision Date April 22, 2008
Days to Decision 42 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
68d faster than avg
Panel avg: 110d · This submission: 42d
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 K080686.
CVUE ADVANCED (HIOXIFILCON D) SOFT (HYDROPHILIC) CONTACT LENS
K082393 · Unilens Corp., USA · Sep 2008
REVITALEYES, POST-SURGICAL SOFT DAILY WEAR CONTACT LENS (HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINT
K080512 · Metro Optics of Austin, Inc. · Jul 2008
INTELLIWAVE, SOFT DAILY WEAR CONTACT LENS (ACOFILCON B) HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINT
K073621 · Art Optical Contact Lens, Inc. · Jul 2008
VISTAKON (NARAFILCON) A SOFT CONTACT LENS
K073485 · Johnson & Johnson Vision Care, Inc. · Mar 2008
CIBA VISION (LOTRAFILCON B) SOFT CONTACT LENSES
K073459 · Ciba Vision Corporation · Feb 2008
CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES
K072777 · Ciba Vision Corporation · Jan 2008
K080686 · WESTCON HORIZON 49% (HIOXIFILCON B)
Download PDF FDA Summary Westcon Contact Lens …