Cleared Special

K092195 - CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD)

K092195 is an FDA 510(k) clearance for CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD), manufactured by Cutera, Inc.. The device is a Class 2 General & Plastic Surgery device with product code NUV cleared through the Special 510(k) pathway after a 72-day FDA review.

K092195 · Cutera, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
72d
Days
Class 2
Risk

K092195 is an FDA 510(k) clearance for the CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD). Classified as Massager, Vacuum, Light Induced Heating (product code NUV), Class II - Special Controls.

Submitted by Cutera, Inc. (Brisbane, US). The FDA issued a Cleared decision on October 1, 2009 after a review of 72 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 - K092195

510(k) Number K092195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2009
Decision Date October 01, 2009
Days to Decision 72 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
43d faster than avg
Panel avg: 115d · This submission: 72d
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 K092195.
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
SMOOTHSHAPES SYSTEM, 11318-120V, 11319-230V
K100230 · Eleme Medical, Inc. · Apr 2010
REACTION SYSTEM
K090221 · Viora , Ltd. · Jul 2009
SMOOTHSHAPES
K083629 · Eleme Medical, Inc. · Feb 2009
ALMA LASERS ACCENT B-SHAPE MASSAGER HANDPIECE/MODULE
K082622 · Alma Lasers , Ltd. · Jan 2009
K092195 · CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD)
Download PDF FDA Summary Cutera, Inc.