Cleared Special

K092195 - CUTERA MULTIMODAL CELLULITE PRODUCT (CM...

K092195 is the FDA 510(k) clearance for CUTERA MULTIMODAL CELLULITE PRODUCT (CM... by Cutera, Inc.. It is a Class 2 General & Plastic Surgery device (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)
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.

View all Cutera, Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 115d · This submission: 72d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 7
Devices cleared under the same product code (NUV) and FDA review panel - the closest regulatory comparables to K092195.
ICOONE Laser Med (also referred to as ICOONE Medical laser)
K211272 · I-Tech Industries Srl · Jun 2021
ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)
K182453 · I-Tech Industries Srl · Jan 2019
VELASHAPE
K122579 · Syneron Medical, Ltd. · Sep 2012
VELASHAPE
K071872 · Syneron Medical, Ltd. · Aug 2007
MODIFICATION TO VELASMOOTH, SHAPER
K070092 · Syneron Medical, Ltd. · Jul 2007
VELASMOOTH, SHAPER
K050397 · Syneron Medical, Ltd. · Jun 2005