Cleared Abbreviated

K992028 - REFRESH CONTACTS LUBRICATING AND REWETT...

K992028 is the FDA 510(k) clearance for REFRESH CONTACTS LUBRICATING AND REWETT... by Allergan, Inc.. It is a Class 2 Ophthalmic device (product code LPN) cleared through the Abbreviated 510(k) pathway after a 113-day FDA review.

K992028 · Allergan, Inc. · Ophthalmic device

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Oct 1999

Decision

113d

Days

Class 2

Risk

K992028 is an FDA 510(k) clearance for the REFRESH CONTACTS 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 October 7, 1999 after a review of 113 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 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.

View all Allergan, Inc. devices

Submission Details

510(k) Number	K992028 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 16, 1999
Decision Date	October 07, 1999
Days to Decision	113 days
Submission Type	Abbreviated
Review Panel	Ophthalmic (OP)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

3d slower than avg

Panel avg: 110d · This submission: 113d

Pathway characteristics

Standards-based clearance path.

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 K992028.

RENU MULTIPLUS MULTI-PURPOSE DISINFECTING SOLUTION

K002823 · Bausch & Lomb, Inc. · Oct 2000

RENU MULTIPLUS MULTI-PURPOSE SOLUTION

K001539 · Bausch & Lomb, Inc. · Jul 2000

BAUSCH & LOMB RENU 1 STEP DAILY PROTEIN REMOVER

K000247 · Bausch & Lomb, Inc. · Apr 2000

OPTI-FREE EXPRESS MULTI-ACTION CLEANING AND REWETTING DROP

K984573 · Alcon Laboratories · Sep 1999

SOLO-CARE BRAND MULTI-PURPOSE SOLUTION

K991403 · Ciba Vision Corporation · Jul 1999

OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER

K990480 · Alcon Laboratories · May 1999

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 K992028

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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