Cleared Traditional

K080300 - CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD)

K080300 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 Traditional 510(k) pathway after a 63-day FDA review.

K080300 · Cutera, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
63d
Days
Class 2
Risk

K080300 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 April 8, 2008 after a review of 63 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cutera, Inc. devices

FDA 510(k) Submission Details - K080300

510(k) Number K080300 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2008
Decision Date April 08, 2008
Days to Decision 63 days
Submission Type Traditional
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
52d faster than avg
Panel avg: 115d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 12
Devices cleared under the same product code (NUV) and FDA review panel - the closest regulatory comparables to K080300.
VELASHAPE
K122579 · Syneron Medical, Ltd. · Sep 2012
MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEM
K101147 · Alma Lasers, Inc. · Jan 2011
CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD)
K092195 · Cutera, Inc. · Oct 2009
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