Cleared Traditional

K050250 - AQUIFY MULTIPURPOSE SOLUTION

K050250 is an FDA 510(k) clearance for AQUIFY MULTIPURPOSE SOLUTION, 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 188-day FDA review.

K050250 · Ciba Vision Corporation · Ophthalmic device
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Aug 2005
Decision
188d
Days
Class 2
Risk

K050250 is an FDA 510(k) clearance for the AQUIFY MULTIPURPOSE 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 August 10, 2005 after a review of 188 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.

View all Ciba Vision Corporation devices

FDA 510(k) Submission Details - K050250

510(k) Number K050250 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2005
Decision Date August 10, 2005
Days to Decision 188 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d slower than avg
Panel avg: 110d · This submission: 188d
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 K050250.
ALCON MULTI-PIRPOSE DISINFECTING SOLUTION
K102860 · Alcon Research, Ltd. · May 2011
REFRESH OPTIVE LENS COMFORT REWETTING DROPS
K083812 · Allergan, Inc. · Jul 2009
ALCON MULTI-PURPOSE DISINFECTING SOLUTION
K050729 · Alcon Research, Ltd. · Sep 2005
AQUIFY LENS COMFORT DROPS
K042176 · Ciba Vision Corporation · Nov 2004
KARATS MULTIPURPOSE SOLUTION
K031753 · Ciba Vision Corporation · Oct 2004
AQUIFY MULTI-PURPOSE SOLUTION
K033608 · Ciba Vision Corporation · Feb 2004