Cleared Special

K142851 - CVue ADVANCED (hioxifilcon D) Soft (hyd...

K142851 is the FDA 510(k) clearance for CVue ADVANCED (hioxifilcon D) Soft (hyd... by Unilens Corp., USA. It is a Class 2 Ophthalmic device (product code LPL) cleared through the Special 510(k) pathway after a 30-day FDA review.

K142851 · Unilens Corp., USA · Ophthalmic device
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Oct 2014
Decision
30d
Days
Class 2
Risk

K142851 is an FDA 510(k) clearance for the CVue ADVANCED (hioxifilcon D) Soft (hydrophilic) Contact Lens. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Unilens Corp., USA (Largo, US). The FDA issued a Cleared decision on October 30, 2014 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Unilens Corp., USA devices

Submission Details

510(k) Number K142851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2014
Decision Date October 30, 2014
Days to Decision 30 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 110d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 140
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K142851.
OxyAqua (olifilcon D) spherical silicone hydrogel soft contact lens, OxyAqua (olifilcon D) multifocal silicone hydrogel soft contact lens, OxyAqua (olifilcon D) toric silicone hydrogel soft contact lens
K173958 · Visco Vision, Inc. · Apr 2018
Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens
K180004 · Menicon Co, Ltd. · Feb 2018
Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens
K160803 · CooperVision, Inc. · Jul 2016
AVAIRA SPHERIC AND TORIC (ENFILCON A) SOFT CONTACT LENS
K133627 · CooperVision, Inc. · Dec 2013
BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA,
K131208 · Bausch & Lomb, Inc. · Sep 2013
SUS (STENFILCON A) CONTACT LENS
K131378 · CooperVision, Inc. · Aug 2013