FDA Product Code
FDA Product Code NUV — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4810
510(k) Clearances — 20 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261582 | Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 2026-08-28 | Traditional | PDF ↗ |
| K231092 | T-SHAPE 2 | B&M S.R.L. Marketing Nel Benessere | 2023-09-22 | Traditional | PDF ↗ |
| K211272 | ICOONE Laser Med (also referred to as ICOONE Medical laser) | I-Tech Industries Srl | 2021-06-22 | Traditional | PDF ↗ |
| K182453 | ICOONE h (also referred to as ICOONE LASER and ICOONE h LASER) | I-Tech Industries Srl | 2019-01-11 | Abbreviated | PDF ↗ |
| K161892 | Slimming Treatment Device | Beijing Honkon Technologies Co., Ltd. | 2017-03-02 | Traditional | PDF ↗ |
| K131362 | INMODE WMBODY DEVICE | Inmode MD , Ltd. | 2013-10-08 | Traditional | PDF ↗ |
| K122579 | VELASHAPE | Syneron Medical, Ltd. | 2012-09-13 | Special | PDF ↗ |
| K101147 | MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEM | Alma Lasers, Inc. | 2011-01-21 | Traditional | PDF ↗ |
| K101366 | I-LIPO, MODELS A00-1238 (230V), A00-1239 (120V) | Chromogenex Technologies, Ltd. | 2010-09-17 | Traditional | PDF ↗ |
| K100230 | SMOOTHSHAPES SYSTEM, 11318-120V, 11319-230V | Eleme Medical, Inc. | 2010-04-02 | Special | PDF ↗ |
| K092195 | CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD) | Cutera, Inc. | 2009-10-01 | Special | PDF ↗ |
| K090221 | REACTION SYSTEM | Viora , Ltd. | 2009-07-01 | Traditional | PDF ↗ |
| K083629 | SMOOTHSHAPES | Eleme Medical, Inc. | 2009-02-19 | Special | PDF ↗ |
| K082622 | ALMA LASERS ACCENT B-SHAPE MASSAGER HANDPIECE/MODULE | Alma Lasers , Ltd. | 2009-01-12 | Traditional | PDF ↗ |
| K080300 | CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD) | Cutera, Inc. | 2008-04-08 | Traditional | PDF ↗ |
| K071872 | VELASHAPE | Syneron Medical, Ltd. | 2007-08-22 | Traditional | PDF ↗ |
| K070092 | MODIFICATION TO VELASMOOTH, SHAPER | Syneron Medical, Ltd. | 2007-07-27 | Traditional | PDF ↗ |
| K061603 | SMOOTHSHAPES | Biocellulase, Inc. | 2006-07-03 | Traditional | PDF ↗ |
| K053611 | SMOOTHSHAPES | Bicellulase, Inc. | 2006-03-15 | Traditional | PDF ↗ |
| K050397 | VELASMOOTH, SHAPER | Syneron Medical, Ltd. | 2005-06-09 | Traditional | PDF ↗ |
Product code NUV · Class II · General, Plastic Surgery. Data: openFDA.