Cleared Traditional

K031646 - BAUSCH & LOMB MULTI-PURPOSE SOLUTION NRC03

K031646 is an FDA 510(k) clearance for BAUSCH & LOMB MULTI-PURPOSE SOLUTION NRC03, manufactured by Bausch & Lomb, Inc.. The device is a Class 2 Ophthalmic device with product code LPN cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K031646 · Bausch & Lomb, Inc. · Ophthalmic device
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Nov 2003
Decision
170d
Days
Class 2
Risk

K031646 is an FDA 510(k) clearance for the BAUSCH & LOMB MULTI-PURPOSE SOLUTION NRC03. Classified as Accessories, Soft Lens Products (product code LPN), Class II - Special Controls.

Submitted by Bausch & Lomb, Inc. (Rochester, US). The FDA issued a Cleared decision on November 14, 2003 after a review of 170 days - an extended review cycle.

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. 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

FDA 510(k) Submission Details - K031646

510(k) Number K031646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2003
Decision Date November 14, 2003
Days to Decision 170 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
60d slower than avg
Panel avg: 110d · This submission: 170d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LPN Device Classification - Class 2, Special Controls

Product Code LPN Accessories, Soft Lens Products
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.

Regulatory Peers - LPN Accessories, Soft Lens Products

All 80
Devices cleared under the same product code (LPN) and FDA review panel - the closest regulatory comparables to K031646.
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AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
K030522 · Ciba Vision Corporation · Sep 2003
MODIFICATION TO KARATS MULTI-PURPOSE SOLUTION
K031957 · Ciba Vision Corporation · Aug 2003
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
K031521 · Ciba Vision Corporation · Jun 2003