NUV — Massager, Vacuum, Light Induced Heating Class II
Classification Details
- Product Code
- NUV
- Device Class
- Class II
- Regulation Number
- 878.4810
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Definition
The device is intended to temporarily alter the appearance of cellulite
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K231092 | b and m s.r.l. marketing nel benessere | T-SHAPE 2 | September 22, 2023 |
| K211272 | i-tech industries | ICOONE Laser Med (also referred to as ICOONE Medical laser) | June 22, 2021 |
| K182453 | i-tech industries | ICOONE h (also referred to as ICOONE LASER and ICOONE h LASER) | January 11, 2019 |
| K161892 | beijing honkon technologies co | Slimming Treatment Device | March 2, 2017 |
| K131362 | inmode md | INMODE WMBODY DEVICE | October 8, 2013 |
| K122579 | syneron medical | VELASHAPE | September 13, 2012 |
| K101147 | alma lasers | MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEM | January 21, 2011 |
| K101366 | chromogenex technologies | I-LIPO, MODELS A00-1238 (230V), A00-1239 (120V) | September 17, 2010 |
| K100230 | eleme medical | SMOOTHSHAPES SYSTEM, 11318-120V, 11319-230V | April 2, 2010 |
| K092195 | cutera | CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD) | October 1, 2009 |
| K090221 | viora | REACTION SYSTEM | July 1, 2009 |
| K083629 | eleme medical | SMOOTHSHAPES | February 19, 2009 |
| K082622 | alma lasers | ALMA LASERS ACCENT B-SHAPE MASSAGER HANDPIECE/MODULE | January 12, 2009 |
| K080300 | cutera | CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD) | April 8, 2008 |
| K071872 | syneron medical | VELASHAPE | August 22, 2007 |
| K070092 | syneron medical | MODIFICATION TO VELASMOOTH, SHAPER | July 27, 2007 |
| K061603 | biocellulase | SMOOTHSHAPES | July 3, 2006 |
| K053611 | bicellulase | SMOOTHSHAPES | March 15, 2006 |
| K050397 | syneron medical | VELASMOOTH, SHAPER | June 9, 2005 |