Cleared Traditional

K002140 - MENICON PROGENT REMOVER

K002140 is an FDA 510(k) clearance for MENICON PROGENT REMOVER, manufactured by Menicon Co, Ltd.. The device is a Class 2 Ophthalmic device with product code MRC cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K002140 · Menicon Co, Ltd. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2000
Decision
85d
Days
Class 2
Risk

K002140 is an FDA 510(k) clearance for the MENICON PROGENT REMOVER. Classified as Products, Contact Lens Care, Rigid Gas Permeable (product code MRC), Class II - Special Controls.

Submitted by Menicon Co, Ltd. (Wilmington, US). The FDA issued a Cleared decision on October 10, 2000 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5918 - 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.

FDA 510(k) Submission Details - K002140

510(k) Number K002140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2000
Decision Date October 10, 2000
Days to Decision 85 days
Submission Type Traditional
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
25d faster than avg
Panel avg: 110d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MRC Device Classification - Class 2, Special Controls

Product Code MRC Products, Contact Lens Care, Rigid Gas Permeable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5918
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 - MRC Products, Contact Lens Care, Rigid Gas Permeable

All 32
Devices cleared under the same product code (MRC) and FDA review panel - the closest regulatory comparables to K002140.
AQUIFY LENS COMFORT DROPS
K013204 · Ciba Vision Corporation · Apr 2002
MODIFICATION TO OPTIMUM CLEANING, DISINFECTING AND
K014162 · Lobob Laboratories, Inc. · Jan 2002
DELTA PLUS MULTIACTION SOLUTION FOR RIGID GAS PERMEABLE CONTACT LENSES
K011456 · Sauflon Pharmaceuticals, Ltd. · Jul 2001
LIPIDURE REWETTING DROPS
K000975 · Nof Corp. · Sep 2000
OPTIMUM CLEANING, DISINFECTING AND STORAGE SOLUTION
K001964 · Lobob Laboratories, Inc. · Jul 2000
OPTI-FREE SUPRACLENS DAILY POTEIN REMOVER / RGP MULTI-PURPOSE DISINFECTING SOLUTION ID 100136
K001235 · Alcon Universal, Ltd. · Jul 2000
K002140 · MENICON PROGENT REMOVER
Download PDF FDA Summary Menicon Co, Ltd.