Cleared Traditional

K083757 - BPZ02 MULTIPURPOSE SOLUTION

K083757 is the FDA 510(k) clearance for BPZ02 MULTIPURPOSE SOLUTION by Bausch & Lomb, Inc.. It is a Class 2 Ophthalmic device (product code LYL) cleared through the Traditional 510(k) pathway after a 336-day FDA review.

K083757 · Bausch & Lomb, Inc. · Ophthalmic device
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Nov 2009
Decision
336d
Days
Class 2
Risk

K083757 is an FDA 510(k) clearance for the BPZ02 MULTIPURPOSE SOLUTION. Classified as Accessories, Solution, Ultrasonic Cleaners For Lenses (product code LYL), Class II - Special Controls.

Submitted by Bausch & Lomb, Inc. (Rochester, US). The FDA issued a Cleared decision on November 18, 2009 after a review of 336 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 K083757 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2008
Decision Date November 18, 2009
Days to Decision 336 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
226d slower than avg
Panel avg: 110d · This submission: 336d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LYL Accessories, Solution, Ultrasonic Cleaners For Lenses
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
NCT00636363 Completed Interventional Industry-sponsored

Safety and Efficacy of a Bausch & Lomb Multipurpose Solution When Compared to Ciba Vision Aquify Multipurpose Solution

541
Patients (actual)
1
Site
Supportive_care
Purpose
Double blind
Masking
Condition studied Contact Lens Solutions
Study design Parallel
Eligibility All sexes · 18 Years+
Principal investigator Mohinder Merchea, OD, PhD
Sponsor Bausch & Lomb Incorporated (industry)
Started 2008-03-01 → Primary completion 2008-08-01
Primary outcome
Slit-lamp Findings > Grade 2
View full study on ClinicalTrials.gov