Cleared Special

K003071 - GLITTER EYES (TEFILCON) SOFT (HYDROPHIL...

K003071 is the FDA 510(k) clearance for GLITTER EYES (TEFILCON) SOFT (HYDROPHIL... by Ciba Vision Corporation. It is a Class 2 Ophthalmic device (product code LPL) cleared through the Special 510(k) pathway after a 72-day FDA review.

K003071 · Ciba Vision Corporation · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2000
Decision
72d
Days
Class 2
Risk

K003071 is an FDA 510(k) clearance for the GLITTER EYES (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR. 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 December 13, 2000 after a review of 72 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 Ciba Vision Corporation devices

Submission Details

510(k) Number K003071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2000
Decision Date December 13, 2000
Days to Decision 72 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
38d faster than avg
Panel avg: 110d · This submission: 72d
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 K003071.
LEO COLORS, LEO ASPHERIC COLORS, LEO TORIC COLORS
K041138 · CooperVision, Inc. · Jul 2004
PROCLEAR COMPATIBLES MULTIFOCAL
K032873 · CooperVision, Inc. · Nov 2003
FREQUENCY 55 UV (METHAFILCON A) SOFT (HYDROPHLIC) CONTACT LENS FOR DAILY WEAR
K020392 · CooperVision, Inc. · Apr 2002
METHAFILCON A
K002625 · CooperVision, Inc. · Sep 2000
POLYMACON
K001089 · CooperVision, Inc. · May 2000
METHAFILCON A
K001090 · CooperVision, Inc. · May 2000