Cleared Abbreviated

K143280 - BHV VIVID (etafilcon A) Soft (Hydrophol...

K143280 is the FDA 510(k) clearance for BHV VIVID (etafilcon A) Soft (Hydrophol... by Brien Holden Vision Pty , Ltd.. It is a Class 2 Ophthalmic device (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

Submission Details

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
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 110d · This submission: 160d
Pathway characteristics
Standards-based clearance path.

Device Classification

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 161
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