Cleared Traditional

K013212 - WAVELENGHT ULTRASOUND LOTION

K013212 is an FDA 510(k) clearance for WAVELENGHT ULTRASOUND LOTION, manufactured by National Therapy Products, Inc.. The device is a Class 2 Radiology device with product code MUI cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K013212 · National Therapy Products, Inc. · Radiology device
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Feb 2002
Decision
153d
Days
Class 2
Risk

K013212 is an FDA 510(k) clearance for the WAVELENGHT ULTRASOUND LOTION. Classified as Media, Coupling, Ultrasound (product code MUI), Class II - Special Controls.

Submitted by National Therapy Products, Inc. (Woodbridge, Ontario, CA). The FDA issued a Cleared decision on February 25, 2002 after a review of 153 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1570 - the FDA radiology and imaging software oversight 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 Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all National Therapy Products, Inc. devices

FDA 510(k) Submission Details - K013212

510(k) Number K013212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2001
Decision Date February 25, 2002
Days to Decision 153 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 107d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MUI Device Classification - Class 2, Special Controls

Product Code MUI Media, Coupling, Ultrasound
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1570
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 Radiology devices follow this clearance model.