Cleared Traditional

K013479 - COMPLETE BRAND MULTI-PURPOSE SOLUTION

K013479 is the FDA 510(k) clearance for COMPLETE BRAND MULTI-PURPOSE SOLUTION by Allergan, Inc.. It is a Class 2 Ophthalmic device (product code LPN) cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K013479 · Allergan, Inc. · Ophthalmic device

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Feb 2002

Decision

115d

Days

Class 2

Risk

K013479 is an FDA 510(k) clearance for the COMPLETE BRAND MULTI-PURPOSE SOLUTION. Classified as Accessories, Soft Lens Products (product code LPN), Class II - Special Controls.

Submitted by Allergan, Inc. (Irvine, US). The FDA issued a Cleared decision on February 11, 2002 after a review of 115 days - within the typical 510(k) review window.

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 Allergan, Inc. devices

Submission Details

510(k) Number	K013479 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 19, 2001
Decision Date	February 11, 2002
Days to Decision	115 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

5d slower than avg

Panel avg: 110d · This submission: 115d

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 52

Devices cleared under the same product code (LPN) and FDA review panel - the closest regulatory comparables to K013479.

AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION

K031521 · Ciba Vision Corporation · Jun 2003

SOLO-CARE PLUS MULTIPURPOSE SOLUTION

K031522 · Ciba Vision Corporation · Jun 2003

KARATS MULTIPURPOSE SOLUTION

K021635 · Ciba Vision Corporation · Oct 2002

SOLO-CARE PLUS MULTIPURPOSE SOLUTION

K012731 · Ciba Vision Corporation · Dec 2001

AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION

K013512 · Ciba Vision Corporation · Dec 2001

RENU MULTIPLUS NO RUB MULTI-PURPOSE SOLUTION

K011796 · Bausch & Lomb, Inc. · Nov 2001

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K013479

Allergan, Inc.

Irvine, CA · US

PAUL J NOWACKI

Regulatory profile

33 submissions 33 cleared

100% clearance rate · Active in Ophthalmic

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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