Cleared Traditional

K013204 - AQUIFY LENS COMFORT DROPS

K013204 is an FDA 510(k) clearance for AQUIFY LENS COMFORT DROPS, 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 190-day FDA review.

K013204 · Ciba Vision Corporation · Ophthalmic device
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Apr 2002
Decision
190d
Days
Class 2
Risk

K013204 is an FDA 510(k) clearance for the AQUIFY LENS COMFORT DROPS. 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 April 3, 2002 after a review of 190 days - an extended review cycle.

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.

View all Ciba Vision Corporation devices

FDA 510(k) Submission Details - K013204

510(k) Number K013204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2001
Decision Date April 03, 2002
Days to Decision 190 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
80d slower than avg
Panel avg: 110d · This submission: 190d
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 21
Devices cleared under the same product code (MRC) and FDA review panel - the closest regulatory comparables to K013204.
BOSTON BL-1000-SIM08 MULTI-ACTION SOLUTION
K024289 · Bausch & Lomb, Incorporated · May 2003
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
K023455 · Ciba Vision Corporation · Feb 2003
MENICON PROGENT REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES
K020930 · Menicon Co, Ltd. · May 2002
MENICON PROGENT REMOVER
K002140 · Menicon Co, Ltd. · Oct 2000
SOLO-CARE BRAND HARD SOLUTION
K000607 · Ciba Vision Corporation · May 2000
RGP MULTI-PURPOSE SOLUTION ID 100136
K000148 · Alcon Laboratories · Apr 2000