Cleared Special

K083216 - CIBA VISION (NELFILCON A) ONE-DAY SOFT ...

K083216 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 Special 510(k) pathway after a 165-day FDA review.

K083216 · Ciba Vision Corporation · Ophthalmic device
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Apr 2009
Decision
165d
Days
Class 2
Risk

K083216 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 April 14, 2009 after a review of 165 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ciba Vision Corporation devices

Submission Details

510(k) Number K083216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2008
Decision Date April 14, 2009
Days to Decision 165 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
55d slower than avg
Panel avg: 110d · This submission: 165d
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 K083216.
PROCLEAR, PROCLEAR TORIC, PROCLEAR MULTIFOCAL, PROCLEAR 1DAY, PROCLEAR XC
K111966 · CooperVision, Inc. · Sep 2011
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