Cleared Traditional

K042176 - AQUIFY LENS COMFORT DROPS

K042176 is the FDA 510(k) clearance for AQUIFY LENS COMFORT DROPS by Ciba Vision Corporation. It is a Class 2 Ophthalmic device (product code LPN) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K042176 · Ciba Vision Corporation · Ophthalmic device
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Nov 2004
Decision
84d
Days
Class 2
Risk

K042176 is an FDA 510(k) clearance for the AQUIFY LENS COMFORT DROPS. 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 November 3, 2004 after a review of 84 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

Submission Details

510(k) Number K042176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2004
Decision Date November 03, 2004
Days to Decision 84 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
26d faster than avg
Panel avg: 110d · This submission: 84d
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 K042176.
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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