Cleared Traditional

K142284 - CLEAR CARE PLUS CLEANING & DISINFECTION...

K142284 is the FDA 510(k) clearance for CLEAR CARE PLUS CLEANING & DISINFECTION... by Alcon Laboratories, Inc.. It is a Class 2 Ophthalmic device (product code LPN) cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K142284 · Alcon Laboratories, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2015
Decision
161d
Days
Class 2
Risk

K142284 is an FDA 510(k) clearance for the CLEAR CARE PLUS CLEANING & DISINFECTIONG SOLUTION WITH HYDRAGLYDE. Classified as Accessories, Soft Lens Products (product code LPN), Class II - Special Controls.

Submitted by Alcon Laboratories, Inc. (Fort Worth, US). The FDA issued a Cleared decision on January 26, 2015 after a review of 161 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 Laboratories, Inc. devices

Submission Details

510(k) Number K142284 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2014
Decision Date January 26, 2015
Days to Decision 161 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
51d slower than avg
Panel avg: 110d · This submission: 161d
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
NCT01912768 Completed Interventional Industry-sponsored

Safety and Efficacy Evaluation of a New Contact Lens Disinfecting Solution in Soft Contact Lens Wearers

Clinical Evaluation of the Safety and Efficacy of FID 120947A Compared to a Marketed Lens Care Solution

362
Patients (actual)
Supportive_care
Purpose
Single blind
Masking
Condition studied Myopia; Astigmatism; Hyperopia; Refractive Error
Study design Parallel
Eligibility All sexes
Principal investigator Monica Studzinski, Lead CSM
Sponsor Alcon Research (industry)
Started 2013-12-01 → Primary completion 2014-05-01
Primary outcome
Percentage of Subjects With Visibly Clean Lenses
View full study on ClinicalTrials.gov

Regulatory Peers - LPN Accessories, Soft Lens Products

All 51
Devices cleared under the same product code (LPN) and FDA review panel - the closest regulatory comparables to K142284.
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