Cleared Traditional

K023455 - AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION

K023455 is an FDA 510(k) clearance for AOSEPT CLEAR CARE CLEANING AND DISINFEC..., manufactured by Ciba Vision Corporation. The device is a Class 2 Ophthalmic device with product code MRC cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K023455 · Ciba Vision Corporation · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2003
Decision
136d
Days
Class 2
Risk

K023455 is an FDA 510(k) clearance for the AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION. Classified as Products, Contact Lens Care, Rigid Gas Permeable (product code MRC), Class II - Special Controls.

Submitted by Ciba Vision Corporation (Duluth, US). The FDA issued a Cleared decision on February 28, 2003 after a review of 136 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K023455

510(k) Number K023455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2002
Decision Date February 28, 2003
Days to Decision 136 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
26d slower than avg
Panel avg: 110d · This submission: 136d
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 K023455.
JSZ-STAT-TREE, AND JSZ-STAT-OR, CLEANING, DISINFECTING AND STORING SOLUTIONS
K052074 · Szabocsik and Associates · Sep 2005
COMPLETE BLINK-N-CLEAN LENS DROPS
K040839 · Advanced Medical Optics, Inc. · Oct 2004
BOSTON BL-1000-SIM08 MULTI-ACTION SOLUTION
K024289 · Bausch & Lomb, Incorporated · May 2003
MENICON PROGENT REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES
K020930 · Menicon Co, Ltd. · May 2002
AQUIFY LENS COMFORT DROPS
K013204 · Ciba Vision Corporation · Apr 2002
MODIFICATION TO OPTIMUM CLEANING, DISINFECTING AND
K014162 · Lobob Laboratories, Inc. · Jan 2002
K023455 · AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
Download PDF FDA Summary Ciba Vision Corporati…