Cleared Abbreviated

K143280 - BHV VIVID (etafilcon A) Soft (Hydropholic) Contact Lens

K143280 is an FDA 510(k) clearance for BHV VIVID (etafilcon A) Soft (Hydrophol..., manufactured by Brien Holden Vision Pty , Ltd.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Abbreviated 510(k) pathway after a 160-day FDA review.

K143280 · Brien Holden Vision Pty , Ltd. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2015
Decision
160d
Days
Class 2
Risk

K143280 is an FDA 510(k) clearance for the BHV VIVID (etafilcon A) Soft (Hydropholic) Contact Lens. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Brien Holden Vision Pty , Ltd. (Sydney, AU). The FDA issued a Cleared decision on April 23, 2015 after a review of 160 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5925 - the FDA ophthalmic device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Brien Holden Vision Pty , Ltd. devices

FDA 510(k) Submission Details - K143280

510(k) Number K143280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2014
Decision Date April 23, 2015
Days to Decision 160 days
Submission Type Abbreviated
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
50d slower than avg
Panel avg: 110d · This submission: 160d
Pathway characteristics
Standards-based clearance path.

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 350
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K143280.
VISCO SOFT CONTACT LENS
K141348 · Visco Vision, Inc. · Jun 2015
BIOLENS Sphere (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear, BIOLENS Toric (mangofilcon A) Soft (hydrophilie) Contact Lens for Daily Wear, BIOLENS Multifocal (mangofilcon A) Soft (hydrophilic) contact lens for daily wear, BIOLENS Toric Multifocal (mangofilcon A) Soft (hydrophilic) contact lens for daily wear
K142820 · Abb Optical Group, LLC · Apr 2015
NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses
K150385 · Visioneering Technologies, Inc. · 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
Giselle (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted)
K143431 · I-Codi Co., Ltd. · Feb 2015