Cleared Traditional

K031521 - AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION

K031521 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 LPN cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K031521 · Ciba Vision Corporation · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2003
Decision
43d
Days
Class 2
Risk

K031521 is an FDA 510(k) clearance for the AOSEPT CLEAR CARE 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 June 27, 2003 after a review of 43 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 Ciba Vision Corporation devices

FDA 510(k) Submission Details - K031521

510(k) Number K031521 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2003
Decision Date June 27, 2003
Days to Decision 43 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
67d faster than avg
Panel avg: 110d · This submission: 43d
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 75
Devices cleared under the same product code (LPN) and FDA review panel - the closest regulatory comparables to K031521.
BAUSCH & LOMB MULTI-PURPOSE SOLUTION NRC03
K031646 · Bausch & Lomb, Inc. · Nov 2003
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
K030522 · Ciba Vision Corporation · Sep 2003
MODIFICATION TO KARATS MULTI-PURPOSE SOLUTION
K031957 · Ciba Vision Corporation · Aug 2003
SOLO-CARE PLUS MULTIPURPOSE SOLUTION
K031522 · Ciba Vision Corporation · Jun 2003
KARATS MULTIPURPOSE SOLUTION
K021635 · Ciba Vision Corporation · Oct 2002
COMPLETE BRAND MULTI-PURPOSE SOLUTION
K014202 · Allergan, Inc. · Feb 2002