Cleared Special

K142851 - CVue ADVANCED (hioxifilcon D) Soft (hydrophilic) Contact Lens

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

K142851 · Unilens Corp., USA · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K142851

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 110d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 K142851.
Intelliwave4
K142641 · Art Optical Contact Lens, Inc. · Jan 2015
Eye Secret 38 UV Aspheric Color(polymacon) Soft(hydrophilic) Contact Lens for Daily
K143052 · Yung Sheng Optical Co., Ltd. · Dec 2014
DESIO (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted)
K142384 · Qualimed Srl · Dec 2014
UNICON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER FOR DAILY WEAR
K141917 · Unicon Optical Co., Ltd. · Oct 2014
AQUAMAX (ETAFILCON A) BI-WEEKLY DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSES
K140025 · Pegavision Corporation · Oct 2014
VASSEN COLOR
K141699 · Vassen Co., Ltd. · Oct 2014
K142851 · CVue ADVANCED (hioxifilcon D) Soft (hydrophilic) Contact Lens
Download PDF FDA Summary Unilens Corp., USA