Cleared Traditional

K003345 - AOSEPT PLUS CLEANING AND DISINFECTING S...

K003345 is the FDA 510(k) clearance for AOSEPT PLUS CLEANING AND DISINFECTING S... by Ciba Vision Corporation. It is a Class 2 Ophthalmic device (product code LPN) cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K003345 · Ciba Vision Corporation · Ophthalmic device
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Mar 2001
Decision
152d
Days
Class 2
Risk

K003345 is an FDA 510(k) clearance for the AOSEPT PLUS CLEANING AND DISINFECTING SOLUTION. Classified as Accessories, Soft Lens Products (product code LPN), Class II - Special Controls.

Submitted by Ciba Vision Corporation (Duluth, US). The FDA issued a Cleared decision on March 26, 2001 after a review of 152 days - an extended review 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: 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.

View all Ciba Vision Corporation devices

Submission Details

510(k) Number K003345 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2000
Decision Date March 26, 2001
Days to Decision 152 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
42d slower than avg
Panel avg: 110d · This submission: 152d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 24
Devices cleared under the same product code (LPN) and FDA review panel - the closest regulatory comparables to K003345.
EZS05 CLEANING AND DISINFECTING SOLUTION, BAUSCH + LOMB EZS05 CLEANING AND DISINFECTING SOLUTION
K111877 · Bausch & Lomb, Inc. · Jan 2012
BAUSCH & LOMB MULTI-PURPOSE SOLUTION NRC03
K031646 · Bausch & Lomb, Inc. · Nov 2003
RENU MULTIPLUS NO RUB MULTI-PURPOSE SOLUTION
K011796 · Bausch & Lomb, Inc. · Nov 2001
RENU MULTIPLUS MULTI-PURPOSE DISINFECTING SOLUTION
K002823 · Bausch & Lomb, Inc. · Oct 2000
RENU MULTIPLUS MULTI-PURPOSE SOLUTION
K001539 · Bausch & Lomb, Inc. · Jul 2000
BAUSCH & LOMB RENU 1 STEP DAILY PROTEIN REMOVER
K000247 · Bausch & Lomb, Inc. · Apr 2000