NUV — Massager, Vacuum, Light Induced Heating Class II
FDA product code NUV covers "Massager, Vacuum, Light Induced Heating", a Class II medical device regulated under 21 CFR 878.4810. Submissions are reviewed by the General, Plastic Surgery panel. At least 19 recent 510(k) clearances have been granted under this product code.
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 |