Cleared Traditional

K131208 - BAUSCH + LOMB PROCOMFORT (SAMFILCON A) ...

K131208 is the FDA 510(k) clearance for BAUSCH + LOMB PROCOMFORT (SAMFILCON A) ... by Bausch & Lomb, Inc.. It is a Class 2 Ophthalmic device (product code LPL) cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K131208 · Bausch & Lomb, Inc. · Ophthalmic device
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Sep 2013
Decision
135d
Days
Class 2
Risk

K131208 is an FDA 510(k) clearance for the BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT.... Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Bausch & Lomb, Inc. (Rochester, US). The FDA issued a Cleared decision on September 11, 2013 after a review of 135 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, Inc. devices

Submission Details

510(k) Number K131208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2013
Decision Date September 11, 2013
Days to Decision 135 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
25d slower than avg
Panel avg: 110d · This submission: 135d
Pathway characteristics
Predicate-based equivalence.

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. 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
NCT01449526 Completed Interventional Industry-sponsored

A Study to Evaluate the Safety and Efficacy of a New Silicone Hydrogel Contact Lens Design

166
Patients (actual)
Double blind
Masking
Condition studied Myopia
Study design Parallel
Eligibility All sexes · 18 Years+
Principal investigator Robert Steffen, OD, MS
Sponsor Bausch & Lomb Incorporated (industry)
Started 2011-08-01 → Primary completion 2011-12-01 → Completed 2012-01-01
Primary outcome
Visual Acuity (VA)
Secondary outcome
Slit Lamp > Grade 2
View full study on ClinicalTrials.gov

Regulatory Peers - LPL Lenses, Soft Contact, Daily Wear

All 139
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K131208.
Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens
K180004 · Menicon Co, Ltd. · Feb 2018
Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens
K160803 · CooperVision, Inc. · Jul 2016
AVAIRA SPHERIC AND TORIC (ENFILCON A) SOFT CONTACT LENS
K133627 · CooperVision, Inc. · Dec 2013
SUS (STENFILCON A) CONTACT LENS
K131378 · CooperVision, Inc. · Aug 2013
PROCLEAR (OMAFILCON A) SOFT HYDROPHILIC) CONTACT LENS
K123202 · CooperVision, Inc. · May 2013
BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VI
K122575 · Bausch & Lomb, Inc. · Dec 2012