Cleared Traditional

K002589 - OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION

K002589 is an FDA 510(k) clearance for OPTI-FREE EXPRESS MULTI-PURPOSE DISINFE..., manufactured by Alcon Universal, Ltd.. The device is a Class 2 Ophthalmic device with product code LPN cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K002589 · Alcon Universal, Ltd. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2000
Decision
63d
Days
Class 2
Risk

K002589 is an FDA 510(k) clearance for the OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION. Classified as Accessories, Soft Lens Products (product code LPN), Class II - Special Controls.

Submitted by Alcon Universal, Ltd. (Fort Worth, US). The FDA issued a Cleared decision on October 23, 2000 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5928 - 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 Alcon Universal, Ltd. devices

FDA 510(k) Submission Details - K002589

510(k) Number K002589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2000
Decision Date October 23, 2000
Days to Decision 63 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
47d faster than avg
Panel avg: 110d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LPN Device Classification - Class 2, Special Controls

Product Code LPN Accessories, Soft Lens Products
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5928
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 - LPN Accessories, Soft Lens Products

All 82
Devices cleared under the same product code (LPN) and FDA review panel - the closest regulatory comparables to K002589.
AOSEPT PLUS CLEANING AND DISINFECTING SOLUTION
K003345 · Ciba Vision Corporation · Mar 2001
COMPLETE BRAND MULTI-PURPOSE SOLUTION
K003252 · Allergan, Inc. · Feb 2001
COMPLETE BRAND LUBRICATING AND REWETTING DROPS
K003109 · Allergan, Inc. · Nov 2000
RENU MULTIPLUS MULTI-PURPOSE DISINFECTING SOLUTION
K002823 · Bausch & Lomb, Inc. · Oct 2000
RENU MULTIPLUS MULTI-PURPOSE SOLUTION
K001539 · Bausch & Lomb, Inc. · Jul 2000
COMPLETE BRAND COMFORTPLUS MULTI-PURPOSE SOLUTION
K000164 · Allergan, Inc. · Jun 2000