Cleared Special

K100230 - SMOOTHSHAPES SYSTEM, 11318-120V, 11319-230V

K100230 is an FDA 510(k) clearance for SMOOTHSHAPES SYSTEM, manufactured by Eleme Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code NUV cleared through the Special 510(k) pathway after a 66-day FDA review.

K100230 · Eleme Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2010
Decision
66d
Days
Class 2
Risk

K100230 is an FDA 510(k) clearance for the SMOOTHSHAPES SYSTEM, 11318-120V, 11319-230V. Classified as Massager, Vacuum, Light Induced Heating (product code NUV), Class II - Special Controls.

Submitted by Eleme Medical, Inc. (Merrimack, US). The FDA issued a Cleared decision on April 2, 2010 after a review of 66 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4810 - 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 - K100230

510(k) Number K100230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2010
Decision Date April 02, 2010
Days to Decision 66 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 115d · This submission: 66d
Pathway characteristics
Modification to existing cleared device.

NUV Device Classification - Class 2, Special Controls

Product Code NUV Massager, Vacuum, Light Induced Heating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition The Device Is Intended To Temporarily Alter The Appearance Of Cellulite
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 - NUV Massager, Vacuum, Light Induced Heating

All 19
Devices cleared under the same product code (NUV) and FDA review panel - the closest regulatory comparables to K100230.
VELASHAPE
K122579 · Syneron Medical, Ltd. · Sep 2012
MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEM
K101147 · Alma Lasers, Inc. · Jan 2011
I-LIPO, MODELS A00-1238 (230V), A00-1239 (120V)
K101366 · Chromogenex Technologies, Ltd. · Sep 2010
CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD)
K092195 · Cutera, Inc. · Oct 2009
REACTION SYSTEM
K090221 · Viora , Ltd. · Jul 2009
SMOOTHSHAPES
K083629 · Eleme Medical, Inc. · Feb 2009
K100230 · SMOOTHSHAPES SYSTEM, 11318-120V, 11319-230V
Download PDF FDA Summary Eleme Medical, Inc.