Cleared Traditional

K010126 - PROSTHETIC, GELFLEX ALPHA, (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED)

K010126 is an FDA 510(k) clearance for PROSTHETIC, manufactured by Cl-Tinters. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K010126 · Cl-Tinters · Ophthalmic device
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Mar 2001
Decision
55d
Days
Class 2
Risk

K010126 is an FDA 510(k) clearance for the PROSTHETIC, GELFLEX ALPHA, (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEA.... Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Cl-Tinters (Colts Neck, US). The FDA issued a Cleared decision on March 12, 2001 after a review of 55 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cl-Tinters devices

FDA 510(k) Submission Details - K010126

510(k) Number K010126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2001
Decision Date March 12, 2001
Days to Decision 55 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
55d faster than avg
Panel avg: 110d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 280
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K010126.
CIBASOFT PROGRESSIVE TORIC (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
K023732 · Ciba Vision Corporation · Dec 2002
FREQUENCY 55 UV (METHAFILCON A) SOFT (HYDROPHLIC) CONTACT LENS FOR DAILY WEAR
K020392 · CooperVision, Inc. · Apr 2002
FOCUS EXCELENS (LOTRAFILCON B) SPHERICAL, TORIC AND MULTIFOCAL DESIGN
K020139 · Ciba Vision Corporation · Apr 2002
GLITTER EYES (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
K003071 · Ciba Vision Corporation · Dec 2000
METHAFILCON A
K002625 · CooperVision, Inc. · Sep 2000
POLYMACON
K001089 · CooperVision, Inc. · May 2000