Cleared Traditional

K042096 - MISONIX INC. SONATHERM 600 ULTRASONIC LESION GENERATING SYSTEM (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K042096 · Misonix, Inc. · General & Plastic Surgery device
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Jan 2006
Decision
540d
Days
Class 2
Risk

K042096 is an FDA 510(k) clearance for the MISONIX INC. SONATHERM 600 ULTRASONIC LESION GENERATING SYSTEM. Classified as System, Ablation, Ultrasound And Accessories (product code NTB), Class II - Special Controls.

Submitted by Misonix, Inc. (Farmingdale, US). The FDA issued a Cleared decision on January 26, 2006 after a review of 540 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - the FDA general and plastic surgery 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Misonix, Inc. devices

Submission Details

510(k) Number K042096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2004
Decision Date January 26, 2006
Days to Decision 540 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
426d slower than avg
Panel avg: 114d · This submission: 540d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NTB System, Ablation, Ultrasound And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Intended For Use As A Surgical Tool For Coagulation And Ablation Of Soft Tissue. This Differs From The Description In The Regulation In That This Device Is Not Intended To Cut Tissue And This Device Uses High Intensity Ultrasound Energy Instead Of Electrosurgery Or Electrocautery.
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 General & Plastic Surgery devices follow this clearance model.