Cleared Traditional

CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD) (K080300) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K080300 · Cutera, Inc. · General & Plastic Surgery device
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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

Submission Details

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
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.

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.