FDA 510(k) Applications for Medical Device Product Code "NUV"
(Massager, Vacuum, Light Induced Heating)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K082622 | ALMA LASERS LTD. | ALMA LASERS ACCENT B-SHAPE MASSAGER HANDPIECE/MODULE | 01/12/2009 |
| K101147 | ALMA LASERS, INC. | MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEM | 01/21/2011 |
| K231092 | B&M S.R.L. Marketing Nel Benessere | T-SHAPE 2 | 09/22/2023 |
| K161892 | BEIJING HONKON TECHNOLOGIES CO., LTD | Slimming Treatment Device | 03/02/2017 |
| K053611 | BICELLULASE, INC. | SMOOTHSHAPES | 03/15/2006 |
| K061603 | BIOCELLULASE, INC. | SMOOTHSHAPES | 07/03/2006 |
| K101366 | CHROMOGENEX TECHNOLOGIES LTD | I-LIPO, MODELS A00-1238 (230V), A00-1239 (120V) | 09/17/2010 |
| K080300 | CUTERA, INC. | CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD) | 04/08/2008 |
| K092195 | CUTERA, INC. | CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD) | 10/01/2009 |
| K083629 | ELEME MEDICAL, INC. | SMOOTHSHAPES | 02/19/2009 |
| K100230 | ELEME MEDICAL, INC. | SMOOTHSHAPES SYSTEM, 11318-120V, 11319-230V | 04/02/2010 |
| K182453 | I-TECH INDUSTRIES SRL | ICOONE h (also referred to as ICOONE LASER and ICOONE ûh LASER) | 01/11/2019 |
| K211272 | I-Tech Industries SRL | ICOONE Laser Med (also referred to as ICOONE Medical laser) | 06/22/2021 |
| K131362 | INMODE MD LTD. | INMODE WMBODY DEVICE | 10/08/2013 |
| K070092 | SYNERON MEDICAL LTD. | MODIFICATION TO VELASMOOTH, SHAPER | 07/27/2007 |
| K122579 | SYNERON MEDICAL LTD. | VELASHAPE | 09/13/2012 |
| K071872 | SYNERON MEDICAL LTD. | VELASHAPE | 08/22/2007 |
| K050397 | SYNERON MEDICAL LTD. | VELASMOOTH, SHAPER | 06/09/2005 |
| K090221 | VIORA LTD. | REACTION SYSTEM | 07/01/2009 |
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