NUV · Class II · 21 CFR 878.4810

FDA Product Code NUV: Massager, Vacuum, Light Induced Heating

The Device Is Intended To Temporarily Alter The Appearance Of Cellulite

Leading manufacturers include Syneron Medical, Ltd., Cutera, Inc. and I-Tech Industries Srl.

20
Total
20
Cleared
113d
Avg days
2005
Since
Stable submission activity - 1 submissions in the last 2 years
Consistent review times: 107d avg (recent)

FDA 510(k) Cleared Massager, Vacuum, Light Induced Heating Devices (Product Code NUV)

20 devices
1–20 of 20
Cleared Aug 28, 2026
Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02)
K261582
Zhengzhou PZ Laser Slim Technology Co., Ltd.
General & Plastic Surgery · 107d
Cleared Sep 22, 2023
T-SHAPE 2
K231092
B&M S.R.L. Marketing Nel Benessere
General & Plastic Surgery · 157d
Cleared Jun 22, 2021
ICOONE Laser Med (also referred to as ICOONE Medical laser)
K211272
I-Tech Industries Srl
General & Plastic Surgery · 56d
Cleared Jan 11, 2019
ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)
K182453
I-Tech Industries Srl
General & Plastic Surgery · 126d
Cleared Mar 02, 2017
Slimming Treatment Device
K161892
Beijing Honkon Technologies Co., Ltd.
General & Plastic Surgery · 234d
Cleared Oct 08, 2013
INMODE WMBODY DEVICE
K131362
Inmode MD , Ltd.
General & Plastic Surgery · 148d
Cleared Sep 13, 2012
VELASHAPE
K122579
Syneron Medical, Ltd.
General & Plastic Surgery · 21d
Cleared Jan 21, 2011
MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEM
K101147
Alma Lasers, Inc.
General & Plastic Surgery · 273d
Cleared Oct 01, 2009
CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD)
K092195
Cutera, Inc.
General & Plastic Surgery · 72d
Cleared Apr 08, 2008
CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD)
K080300
Cutera, Inc.
General & Plastic Surgery · 63d
Cleared Aug 22, 2007
VELASHAPE
K071872
Syneron Medical, Ltd.
General & Plastic Surgery · 47d
Cleared Jul 27, 2007
MODIFICATION TO VELASMOOTH, SHAPER
K070092
Syneron Medical, Ltd.
General & Plastic Surgery · 198d
Cleared Jun 09, 2005
VELASMOOTH, SHAPER
K050397
Syneron Medical, Ltd.
General & Plastic Surgery · 113d

About Product Code NUV - Regulatory Context

510(k) Submission Activity

20 total 510(k) submissions under product code NUV since 2005, with 20 receiving FDA clearance (average review time: 113 days).

Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.

FDA 510(k) Review Time - NUV Product Code

FDA review times for NUV submissions have been consistent, averaging 107 days recently vs 113 days historically.

NUV devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →