Cleared Traditional

K132715 - BAUSCH + LOMB BIOTURE ONEDAY FOR PRESBY...

K132715 is the FDA 510(k) clearance for BAUSCH + LOMB BIOTURE ONEDAY FOR PRESBY... by Bausch & Lomb, Incorporated. It is a Class 2 Ophthalmic device (product code LPL) cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K132715 · Bausch & Lomb, Incorporated · Ophthalmic device
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Dec 2013
Decision
112d
Days
Class 2
Risk

K132715 is an FDA 510(k) clearance for the BAUSCH + LOMB BIOTURE ONEDAY FOR PRESBYOPIA (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 December 20, 2013 after a review of 112 days - within the typical 510(k) review window.

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

Submission Details

510(k) Number K132715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2013
Decision Date December 20, 2013
Days to Decision 112 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 110d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - LPL Lenses, Soft Contact, Daily Wear

All 161
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K132715.
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K153643 · Alcon Laboratories, Inc. · Jan 2016
AIR OPTIX COLORS, AIR OPTIX COLORS TORIC, AIR OPTIX COLORS MULTIFOCAL
K133176 · Ciba Vision Corporation · Jan 2014
AVAIRA SPHERIC AND TORIC (ENFILCON A) SOFT CONTACT LENS
K133627 · CooperVision, Inc. · Dec 2013
BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA,
K131208 · Bausch & Lomb, Inc. · Sep 2013
SUS (STENFILCON A) CONTACT LENS
K131378 · CooperVision, Inc. · Aug 2013
PROCLEAR (OMAFILCON A) SOFT HYDROPHILIC) CONTACT LENS
K123202 · CooperVision, Inc. · May 2013