Cleared Special

K003071 - GLITTER EYES (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR

K003071 is an FDA 510(k) clearance for GLITTER EYES (TEFILCON) SOFT (HYDROPHIL..., manufactured by Ciba Vision Corporation. The device is a Class 2 Ophthalmic device with 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) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K003071

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 110d · This submission: 72d
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 K003071.
OCULAR SCIENCES, INC. BIOMEDICS 52 (OCUFILCON D) UV BLOCKING DAILY WEAR SOFT CONTACT LENS
K003136 · Ocular Sciences Puerto Rico, Inc. · Jan 2001
ESSTECH MULTI TORIC ASPHERIC (MULTIFOCAL) (HIOXIFILCON B) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (CLEAR AND TINT
K003161 · Les Laboratoires Blanchard · Dec 2000
RYTHMIC AND RYTHMIC UV
K003170 · Essilor Intl. · Dec 2000
SPECIALTY TINT SOFT CONTACT LENS
K003079 · Specialty Tint · Nov 2000
OCU-FLEX-49 SPHERICAL, TORIC, ASPHERICAL AND TORIC ASPHERICAL (HIOXIFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR
K002966 · Ocu-Ease Optical Products, Inc. · Nov 2000
AXION PLUS (METHAFILCON A) SOFT (HYDROPHILIC) ASPHERIC CONTRACT LENS
K002408 · Unilens Corp., USA · Oct 2000
K003071 · GLITTER EYES (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
Download PDF FDA Summary Ciba Vision Corporati…