Cleared Traditional

K072777 - CIBA VISION (NELFILCON A) ONE-DAY SOFT ...

K072777 is the FDA 510(k) clearance for CIBA VISION (NELFILCON A) ONE-DAY SOFT ... by Ciba Vision Corporation. It is a Class 2 Ophthalmic device (product code LPL) cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K072777 · Ciba Vision Corporation · Ophthalmic device
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Jan 2008
Decision
118d
Days
Class 2
Risk

K072777 is an FDA 510(k) clearance for the CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Ciba Vision Corporation (Duluth, US). The FDA issued a Cleared decision on January 24, 2008 after a review of 118 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Ciba Vision Corporation devices

Submission Details

510(k) Number K072777 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2007
Decision Date January 24, 2008
Days to Decision 118 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 110d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K072777.
PROCLEAR TORIC XR SOFT (HYDROPHILIC) CONTACT LENS
K110099 · CooperVision, Inc. · Jun 2011
BIOMEDICS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS
K091339 · CooperVision, Inc. · Jan 2010
PROCLEAR MULTIFOCAL TORIC AND XR AND TORIC XR
K081865 · CooperVision, Inc. · Sep 2008
AQUAIR (ENFILCON A) SOFT (HYDROPHILIC) CONTACT LENS
K071736 · CooperVision, Inc. · Jan 2008
BIOFINITY (COMFILCON A) SOFT CONTACT LENS
K052560 · CooperVision, Inc. · Dec 2005
PUREVISION MULTI-FOCAL (BALAFILCON A) VISIBILITY TINTED CONTACT LENS
K050948 · Bausch & Lomb, Inc. · May 2005