Cleared Abbreviated

K003109 - COMPLETE BRAND LUBRICATING AND REWETTING DROPS

K003109 is an FDA 510(k) clearance for COMPLETE BRAND LUBRICATING AND REWETTIN..., manufactured by Allergan, Inc.. The device is a Class 2 Ophthalmic device with product code LPN cleared through the Abbreviated 510(k) pathway after a 48-day FDA review.

K003109 · Allergan, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2000
Decision
48d
Days
Class 2
Risk

K003109 is an FDA 510(k) clearance for the COMPLETE BRAND LUBRICATING AND REWETTING DROPS. 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 November 21, 2000 after a review of 48 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K003109

510(k) Number K003109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2000
Decision Date November 21, 2000
Days to Decision 48 days
Submission Type Abbreviated
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
62d faster than avg
Panel avg: 110d · This submission: 48d
Pathway characteristics
Standards-based clearance path.

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 K003109.
AOSEPT PLUS CLEANING AND DISINFECTING SOLUTION
K003345 · Ciba Vision Corporation · Mar 2001
COMPLETE BRAND MULTI-PURPOSE SOLUTION
K003252 · Allergan, Inc. · Feb 2001
LENSOCLEAN MULTI-PURPOSE SOLUTION, MODEL 355ML
K003031 · Alpha Vista, Inc. · Jan 2001
OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION
K002589 · Alcon Universal, Ltd. · Oct 2000
RENU MULTIPLUS MULTI-PURPOSE DISINFECTING SOLUTION
K002823 · Bausch & Lomb, Inc. · Oct 2000
PURILENS SALINE SOLUTION
K002319 · Purilens, Inc. · Aug 2000
K003109 · COMPLETE BRAND LUBRICATING AND REWETTING DROPS
Download PDF FDA Summary Allergan, Inc.