Cleared Special

K112626 - LIPSONIX(R) SYSTEM MODEL 2

K112626 is an FDA 510(k) clearance for LIPSONIX SYSTEM MODEL 2, manufactured by Medicis Technologies Corporation. The device is a Class 2 General & Plastic Surgery device with product code OHV cleared through the Special 510(k) pathway after a 41-day FDA review.

K112626 · Medicis Technologies Corporation · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2011
Decision
41d
Days
Class 2
Risk

K112626 is an FDA 510(k) clearance for the LIPSONIX(R) SYSTEM MODEL 2. Classified as Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption (product code OHV), Class II - Special Controls.

Submitted by Medicis Technologies Corporation (Bothell, US). The FDA issued a Cleared decision on October 20, 2011 after a review of 41 days - a notably fast clearance cycle.

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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K112626

510(k) Number K112626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2011
Decision Date October 20, 2011
Days to Decision 41 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 115d · This submission: 41d
Pathway characteristics
Modification to existing cleared device.

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.

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

All 29
Devices cleared under the same product code (OHV) and FDA review panel - the closest regulatory comparables to K112626.
ULTHERA SYSTEM
K132028 · Ulthera, Inc. · Dec 2013
ULTHERA SYSTEM
K121700 · Ulthera, Inc. · Oct 2012
ULTHERA SYSTEM
K122528 · Ulthera, Inc. · Aug 2012
LIPOSONIX SYSTEM, MODEL 1 P00XXXX
K100874 · Medicis Technologies Corporation · Aug 2011
ULTHERA SYSTEM, MODEL 8850-0001
DEN080006 · Ulthera, Inc. · Sep 2009
K112626 · LIPSONIX(R) SYSTEM MODEL 2
Download PDF FDA Summary Medicis Technologies …