Cleared Traditional

K100874 - LIPOSONIX SYSTEM, MODEL 1 P00XXXX

K100874 is an FDA 510(k) clearance for LIPOSONIX SYSTEM, manufactured by Medicis Technologies Corporation. The device is a Class 2 General & Plastic Surgery device with product code OHV cleared through the Traditional 510(k) pathway after a 507-day FDA review.

K100874 · Medicis Technologies Corporation · General & Plastic Surgery device
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Aug 2011
Decision
507d
Days
Class 2
Risk

K100874 is an FDA 510(k) clearance for the LIPOSONIX SYSTEM, MODEL 1 P00XXXX. Classified as Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption (product code OHV), Class II - Special Controls.

Submitted by Medicis Technologies Corporation (Washington, US). The FDA issued a Cleared decision on August 19, 2011 after a review of 507 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 878.4590 - 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 Medicis Technologies Corporation devices

FDA 510(k) Submission Details - K100874

510(k) Number K100874 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2010
Decision Date August 19, 2011
Days to Decision 507 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
392d slower than avg
Panel avg: 115d · This submission: 507d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OHV Device Classification - Class 2, Special Controls

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.