Cleared Traditional

K113703 - BAUSCH + LOMB NESOFILCON A CONTACT LENS

K113703 is an FDA 510(k) clearance for BAUSCH + LOMB NESOFILCON A CONTACT LENS, manufactured by Bausch & Lomb, Incorporated. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K113703 · Bausch & Lomb, Incorporated · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2012
Decision
172d
Days
Class 2
Risk

K113703 is an FDA 510(k) clearance for the BAUSCH + LOMB NESOFILCON A CONTACT LENS. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Bausch & Lomb, Incorporated (Rochester, US). The FDA issued a Cleared decision on June 5, 2012 after a review of 172 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5925 - 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 Bausch & Lomb, Incorporated devices

FDA 510(k) Submission Details - K113703

510(k) Number K113703 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2011
Decision Date June 05, 2012
Days to Decision 172 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
62d slower than avg
Panel avg: 110d · This submission: 172d
Pathway characteristics
Predicate-based equivalence.

LPL Device Classification - Class 2, Special Controls

Product Code LPL Lenses, Soft Contact, Daily Wear
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5925
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
NCT01365039 Completed Interventional Industry-sponsored

Safety and Efficacy of a Contact Lens for Daily Disposable Use

A Study to Evaluate the Safety and Efficacy of a Novel Contact Lens for Daily Disposable Use

173
Patients (actual)
1
Site
Single blind
Masking
Condition studied Myopia
Study design Parallel
Eligibility All sexes · 18 Years+
Principal investigator Beverly Barna, CCRA
Sponsor Bausch & Lomb Incorporated (industry)
Started 2011-06-01 → Primary completion 2011-10-01
Primary outcome
Slit Lamp Findings > Grade 2
View full study on ClinicalTrials.gov

Regulatory Peers - LPL Lenses, Soft Contact, Daily Wear

All 349
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K113703.
ISIGHT
K121519 · C&E GP Specialists, Inc. · Sep 2012
AVT NATURASOFT
K121324 · Advanced Vision Technologies · Aug 2012
CALAVIEW COLOR (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR MODIFICATION
K112373 · Innova Vision, Inc. · Aug 2012
GEO MAGIC COLOR (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS
K110835 · GEO MEDICAL CO., LTD. · Apr 2012
AQUAMAX (ETAFILCON A) DISPOSABLE SOFT CONTACT LENSES
K120028 · Pegavision Corporation · Apr 2012
AVAIRA (ENFILCON A) CONTACT LENS
K113759 · CooperVision, Inc. · Apr 2012