Cleared Traditional

REFRESH RELIEVA For CONTACTS (K190674) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through predicate-based substantial equivalence.

K190674 · Allergan, Inc. · Ophthalmic device
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Aug 2019
Decision
146d
Days
Class 2
Risk

K190674 is an FDA 510(k) clearance for the REFRESH RELIEVA For CONTACTS. 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 August 8, 2019 after a review of 146 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 K190674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2019
Decision Date August 08, 2019
Days to Decision 146 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
36d slower than avg
Panel avg: 110d · This submission: 146d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Ophthalmic devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01844388 Completed Interventional Industry-sponsored

A Study to Compare a New Eye Drop Formulation With Refresh Contacts®

365
Patients (actual)
1
Site
Treatment
Purpose
Double blind
Masking
Condition studied Contact Lens Lubrication
Study design Parallel
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator Medical Director
Sponsor Allergan (industry)
Started 2013-05-29 → Primary completion 2013-12-02
Primary outcome
Percentage of Participants With Contact Lens Distance Visual Acuity Change From Baseline
View full study on ClinicalTrials.gov

Regulatory Peers - LPN Accessories, Soft Lens Products

All 119
Devices cleared under the same product code (LPN) and FDA review panel - the closest regulatory comparables to K190674.
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K202932 · Bausch & Lomb, Incorporated · May 2021
OTE MPS 045 Multi-purpose Lens Care Solution
K210051 · Ote North America, LLC · May 2021
Aqua Naina Sterile Saline Solution
K193441 · Chemtex USA, Inc. · May 2020
PuriLens Plus Preservative Free Saline
K200747 · The Lifestyle Company, Inc. · May 2020