Panels › General, Plastic Surgery › Product code NUV · Class 2
Massager, Vacuum, Light Induced Heating
Regulation 878.4810
1510(k)s in 12 months (20 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in NUV
| Company | 510(k)s | Recalls |
|---|---|---|
| Syneron Medical, Ltd. | 4 | 0 |
| Alma Lasers , Ltd. | 2 | 0 |
| Cutera, Inc. | 2 | 0 |
| Eleme Medical, Inc. | 2 | 0 |
| I-Tech Industries Srl | 2 | 0 |
| B&M S.R.L. Marketing Nel Benessere | 1 | 0 |
| Beijing Honkon Technologies Co., Ltd. | 1 | 0 |
| Bicellulase, Inc. | 1 | 0 |
| Biocellulase, Inc. | 1 | 0 |
| Chromogenex Technologies, Ltd. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 28, 2026 | K261582 | Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02) Zhengzhou PZ Laser Slim Technology Co., Ltd., CN | NUV |
| Sep 22, 2023 | K231092 | T-SHAPE 2 B&M S.R.L. Marketing Nel Benessere, IT | NUV |
| Jun 22, 2021 | K211272 | ICOONE Laser Med (also referred to as ICOONE Medical laser) I-Tech Industries Srl, IT | NUV |
| Jan 11, 2019 | K182453 | ICOONE h (also referred to as ICOONE LASER and ICOONE h LASER) I-Tech Industries Srl, IT | NUV |
| Mar 2, 2017 | K161892 | Slimming Treatment Device Beijing Honkon Technologies Co., Ltd., CN | NUV |
| Oct 8, 2013 | K131362 | INMODE WMBODY DEVICE Inmode MD , Ltd., IL | NUV |
| Sep 13, 2012 | K122579 | VELASHAPE Syneron Medical, Ltd., IL | NUV |
| Jan 21, 2011 | K101147 | MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEM Alma Lasers, Inc. | NUV |
| Sep 17, 2010 | K101366 | I-LIPO, MODELS A00-1238 (230V), A00-1239 (120V) Chromogenex Technologies, Ltd., GB | NUV |
| Apr 2, 2010 | K100230 | SMOOTHSHAPES SYSTEM, 11318-120V, 11319-230V Eleme Medical, Inc. | NUV |
| Oct 1, 2009 | K092195 | CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD) Cutera, Inc. | NUV |
| Jul 1, 2009 | K090221 | REACTION SYSTEM Viora , Ltd. | NUV |
| Feb 19, 2009 | K083629 | SMOOTHSHAPES Eleme Medical, Inc. | NUV |
| Jan 12, 2009 | K082622 | ALMA LASERS ACCENT B-SHAPE MASSAGER HANDPIECE/MODULE Alma Lasers , Ltd. | NUV |
| Apr 8, 2008 | K080300 | CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD) Cutera, Inc. | NUV |
| Aug 22, 2007 | K071872 | VELASHAPE Syneron Medical, Ltd., IL | NUV |
| Jul 27, 2007 | K070092 | MODIFICATION TO VELASMOOTH, SHAPER Syneron Medical, Ltd., IL | NUV |
| Jul 3, 2006 | K061603 | SMOOTHSHAPES Biocellulase, Inc. | NUV |
| Mar 15, 2006 | K053611 | SMOOTHSHAPES Bicellulase, Inc. | NUV |
| Jun 9, 2005 | K050397 | VELASMOOTH, SHAPER Syneron Medical, Ltd. | NUV |
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