Cleared Traditional

K150019 - TheraVision Ultrasound Ablation System and ACOUSTx Applicators (FDA 510(k) Clearance)

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

K150019 · Acoustic Medsystems, Inc. · General & Plastic Surgery device
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Jan 2016
Decision
373d
Days
Class 2
Risk

K150019 is an FDA 510(k) clearance for the TheraVision Ultrasound Ablation System and ACOUSTx Applicators. Classified as System, Ablation, Ultrasound And Accessories (product code NTB), Class II - Special Controls.

Submitted by Acoustic Medsystems, Inc. (Savoy, US). The FDA issued a Cleared decision on January 13, 2016 after a review of 373 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Acoustic Medsystems, Inc. devices

Submission Details

510(k) Number K150019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 2015
Decision Date January 13, 2016
Days to Decision 373 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
259d slower than avg
Panel avg: 114d · This submission: 373d
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.