Cleared Traditional

K013204 - AQUIFY LENS COMFORT DROPS (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

Device Classification

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

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