Cleared Traditional

K013479 - COMPLETE BRAND MULTI-PURPOSE SOLUTION

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

K013479 · Allergan, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K013479

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
Combination Product No
PCCP Authorized No
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.

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 120
Devices cleared under the same product code (LPN) and FDA review panel - the closest regulatory comparables to K013479.
KARATS MULTIPURPOSE SOLUTION
K021635 · Ciba Vision Corporation · Oct 2002
OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION
K021143 · Alcon Universal, Ltd. · Aug 2002
COMPLETE BRAND MULTI-PURPOSE SOLUTION
K014202 · Allergan, Inc. · Feb 2002
SOLO-CARE PLUS MULTIPURPOSE SOLUTION
K012731 · Ciba Vision Corporation · Dec 2001
SAUFLON MULTI LENS CARE SYSTEM
K010559 · Sauflon Pharmaceuticals, Ltd. · Dec 2001
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
K013512 · Ciba Vision Corporation · Dec 2001
K013479 · COMPLETE BRAND MULTI-PURPOSE SOLUTION
Download PDF FDA Summary Allergan, Inc.