Not Cleared Post-NSE

DEN080006 - ULTHERA SYSTEM, MODEL 8850-0001 (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Post-NSE 510(k) pathway - typically does not require clinical trials.

DEN080006 · Ulthera, Inc. · General & Plastic Surgery device
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Sep 2009
Decision
518d
Days
Class 2
Risk

DEN080006 is an FDA 510(k) submission (not cleared) for the ULTHERA SYSTEM, MODEL 8850-0001. Classified as Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption (product code OHV), Class II - Special Controls.

Submitted by Ulthera, Inc. (Mesa, US). The FDA issued a Not Cleared (DENG) decision on September 11, 2009 after a review of 518 days.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4590 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 518 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Ulthera, Inc. devices

Submission Details

510(k) Number DEN080006 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received April 11, 2008
Decision Date September 11, 2009
Days to Decision 518 days
Submission Type Post-NSE
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
404d slower than avg
Panel avg: 114d · This submission: 518d
Pathway characteristics

Device Classification

Product Code OHV Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4590
Definition A Device Using Focused Ultrasound To Produce Localized, Mechanical Motion Within Tissues And Cells For The Purpose Of Producing Either Localized Heating For Tissue Coagulation Or For Mechanical Cellular Membrane Disruption Intended For Non-invasive Aesthetic Use.
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.

Regulatory Peers - OHV Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption

All 28
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