Cleared Special

K122579 - VELASHAPE

K122579 is the FDA 510(k) clearance for VELASHAPE by Syneron Medical, Ltd.. It is a Class 2 General & Plastic Surgery device (product code NUV) cleared through the Special 510(k) pathway after a 21-day FDA review.

K122579 · Syneron Medical, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
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Sep 2012
Decision
21d
Days
Class 2
Risk

K122579 is an FDA 510(k) clearance for the VELASHAPE. Classified as Massager, Vacuum, Light Induced Heating (product code NUV), Class II - Special Controls.

Submitted by Syneron Medical, Ltd. (Yokneam, Illit, IL). The FDA issued a Cleared decision on September 13, 2012 after a review of 21 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 Syneron Medical, Ltd. devices

Submission Details

510(k) Number K122579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2012
Decision Date September 13, 2012
Days to Decision 21 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
94d faster than avg
Panel avg: 115d · This submission: 21d
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

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