Cleared Traditional

BPZ02 MULTIPURPOSE SOLUTION (K083757) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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
Regulatory Context
Review time vs. panel average
226d slower than avg
Panel avg: 110d · This submission: 336d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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