Cleared Traditional

K030522 - AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION

K030522 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 205-day FDA review.

K030522 · Ciba Vision Corporation · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2003
Decision
205d
Days
Class 2
Risk

K030522 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 September 12, 2003 after a review of 205 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.

FDA 510(k) Submission Details - K030522

510(k) Number K030522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2003
Decision Date September 12, 2003
Days to Decision 205 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
95d slower than avg
Panel avg: 110d · This submission: 205d
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 113
Devices cleared under the same product code (LPN) and FDA review panel - the closest regulatory comparables to K030522.
THERATEARS CONTACT LENS COMFORT DROPS
K032481 · Advanced Vision Research, Inc. · Nov 2003
CLUED UP MULTIPURPOSE SOLUTION- NO RUB
K030910 · Clued UP Limited · Oct 2003
BLINK CL LUBRICANT EYE DROPS
K032030 · Advanced Medical Optics, Inc. · Sep 2003
MODIFICATION TO KARATS MULTI-PURPOSE SOLUTION
K031957 · Ciba Vision Corporation · Aug 2003
SAUFLON MULTIPURPOSE SOLUTION - NO RUB
K030278 · Sauflon Pharmaceuticals, Ltd. · Jul 2003
SOFT (HYDROPHILIC) CONTACT LENS CARE SOLUTION
K031193 · Alcon, Inc. · Jul 2003
K030522 · AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
Download PDF FDA Summary Ciba Vision Corporati…