Cleared Traditional

K102860 - ALCON MULTI-PIRPOSE DISINFECTING SOLUTION

K102860 is an FDA 510(k) clearance for ALCON MULTI-PIRPOSE DISINFECTING SOLUTION, manufactured by Alcon Research, Ltd.. The device is a Class 2 Ophthalmic device with product code LPN cleared through the Traditional 510(k) pathway after a 222-day FDA review.

K102860 · Alcon Research, Ltd. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
222d
Days
Class 2
Risk

K102860 is an FDA 510(k) clearance for the ALCON MULTI-PIRPOSE DISINFECTING SOLUTION. Classified as Accessories, Soft Lens Products (product code LPN), Class II - Special Controls.

Submitted by Alcon Research, Ltd. (Fort Worth, US). The FDA issued a Cleared decision on May 10, 2011 after a review of 222 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 Alcon Research, Ltd. devices

FDA 510(k) Submission Details - K102860

510(k) Number K102860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2010
Decision Date May 10, 2011
Days to Decision 222 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
112d slower than avg
Panel avg: 110d · This submission: 222d
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
NCT01341977 Completed Interventional Industry-sponsored

Safety and Efficacy of an Investigational Multi-Purpose Disinfecting Solution

Safety and Efficacy of an Investigational Multi-Purpose Disinfecting Solution (MPDS)

573
Patients (actual)
1
Site
Supportive_care
Purpose
Triple
Masking
Condition studied Healthy Contact Lens Wearers
Study design Parallel
Eligibility All sexes · Healthy volunteers accepted
Principal investigator Jessie M Lemp, MS
Sponsor Alcon Research (industry)
Started 2009-11-01 → Primary completion 2010-05-01
Primary outcome
Subjective Acceptance
View full study on ClinicalTrials.gov

Regulatory Peers - LPN Accessories, Soft Lens Products

All 85
Devices cleared under the same product code (LPN) and FDA review panel - the closest regulatory comparables to K102860.
OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION
K112909 · Bausch & Lomb, Inc. · Apr 2012
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
REFRESH OPTIVE LENS COMFORT REWETTING DROPS
K083812 · Allergan, Inc. · Jul 2009
EYE SEE MULTIPURPOSE, NO-RUB CONTACT LENS SOLUTION
K051104 · Lapis Lazuli, NV · May 2006
ALCON MULTI-PURPOSE DISINFECTING SOLUTION
K050729 · Alcon Research, Ltd. · Sep 2005