Cleared Traditional

K083812 - REFRESH OPTIVE LENS COMFORT REWETTING DROPS

K083812 is an FDA 510(k) clearance for REFRESH OPTIVE LENS COMFORT REWETTING DROPS, 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 199-day FDA review.

K083812 · Allergan, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
199d
Days
Class 2
Risk

K083812 is an FDA 510(k) clearance for the REFRESH OPTIVE LENS COMFORT REWETTING DROPS. Classified as Accessories, Soft Lens Products (product code LPN), Class II - Special Controls.

Submitted by Allergan, Inc. (Wilmington, US). The FDA issued a Cleared decision on July 9, 2009 after a review of 199 days - an extended review cycle.

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

FDA 510(k) Submission Details - K083812

510(k) Number K083812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2008
Decision Date July 09, 2009
Days to Decision 199 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
89d slower than avg
Panel avg: 110d · This submission: 199d
Pathway characteristics
Predicate-based equivalence.

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. 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
NCT00691197 Completed Interventional Industry-sponsored

Safety and Acceptability of Using a Rewetting Drop With Contact Lens Wear

246
Patients (actual)
1
Site
Treatment
Purpose
Triple
Masking
Condition studied Ametropia
Study design Parallel
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator Medical Director
Sponsor Allergan (industry)
Started 2008-03-01 → Primary completion 2008-10-01
Primary outcome
Best Corrected Visual Acuity
Secondary outcome
Corneal Staining
View full study on ClinicalTrials.gov

Regulatory Peers - LPN Accessories, Soft Lens Products

All 83
Devices cleared under the same product code (LPN) and FDA review panel - the closest regulatory comparables to K083812.
EZS05 CLEANING AND DISINFECTING SOLUTION, BAUSCH + LOMB EZS05 CLEANING AND DISINFECTING SOLUTION
K111877 · Bausch & Lomb, Inc. · Jan 2012
EYE-CEPT STERILE SALINE SOLUTION
K110221 · Optics Laboratory, Inc. · Nov 2011
ALCON MULTI-PIRPOSE DISINFECTING SOLUTION
K102860 · Alcon Research, Ltd. · May 2011
ALCON MULTI-PURPOSE DISINFECTING SOLUTION
K050729 · Alcon Research, Ltd. · Sep 2005
AQUIFY MULTIPURPOSE SOLUTION
K050250 · Ciba Vision Corporation · Aug 2005
LENS PLUS REWETTING DROPS
K042562 · Advanced Medical Optics, Inc. · Jul 2005