Product code NUV
- Device name
- Massager, Vacuum, Light Induced Heating
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.4810
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Definition
- The device is intended to temporarily alter the appearance of cellulite
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K231092 | T-SHAPE 2 | B&M S.R.L. Marketing Nel Benessere | 2023-09-22 |
| K211272 | ICOONE Laser Med (also referred to as ICOONE Medical laser) | I-Tech Industries Srl | 2021-06-22 |
| K182453 | ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER) | I-Tech Industries Srl | 2019-01-11 |
| K161892 | Slimming Treatment Device | Beijing Honkon Technologies Co., Ltd. | 2017-03-02 |
| K131362 | INMODE WMBODY DEVICE | Inmode MD , Ltd. | 2013-10-08 |
| K122579 | VELASHAPE | Syneron Medical, Ltd. | 2012-09-13 |
| K101147 | MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEM | Alma Lasers, Inc. | 2011-01-21 |
| K101366 | I-LIPO, MODELS A00-1238 (230V), A00-1239 (120V) | Chromogenex Technologies, Ltd. | 2010-09-17 |
| K100230 | SMOOTHSHAPES SYSTEM, 11318-120V, 11319-230V | Eleme Medical, Inc. | 2010-04-02 |
| K092195 | CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD) | Cutera, Inc. | 2009-10-01 |
| K090221 | REACTION SYSTEM | Viora , Ltd. | 2009-07-01 |
| K083629 | SMOOTHSHAPES | Eleme Medical, Inc. | 2009-02-19 |
| K082622 | ALMA LASERS ACCENT B-SHAPE MASSAGER HANDPIECE/MODULE | Alma Lasers , Ltd. | 2009-01-12 |
| K080300 | CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD) | Cutera, Inc. | 2008-04-08 |
| K071872 | VELASHAPE | Syneron Medical, Ltd. | 2007-08-22 |
| K070092 | MODIFICATION TO VELASMOOTH, SHAPER | Syneron Medical, Ltd. | 2007-07-27 |
| K061603 | SMOOTHSHAPES | Biocellulase, Inc. | 2006-07-03 |
| K053611 | SMOOTHSHAPES | Bicellulase, Inc. | 2006-03-15 |
| K050397 | VELASMOOTH, SHAPER | Syneron Medical, Ltd. | 2005-06-09 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07290019863359 | ApexRF Applicator | INMODE M.D LTD | 2025-06-04 |
| 07290016746433 | ST Single Use Tip | VIORA LTD | 2025-06-03 |
| 07290019863342 | APEX RF System | INMODE M.D LTD | 2025-01-09 |
| 07290019863311 | InMode OP | INMODE M.D LTD | 2024-03-24 |
| 07290016633726 | Envision System | INMODE M.D LTD | 2024-03-24 |
| 07290019863014 | CelluTite System | INMODE M.D LTD | 2024-03-19 |
| 18057592610369 | Icoone Laser Body | I-TECH INDUSTRIES SRL | 2023-11-30 |
| 18057592610307 | Icoone Laser | I-TECH INDUSTRIES SRL | 2023-11-30 |
| 18057592610277 | Icoone Laser Med | I-TECH INDUSTRIES SRL | 2023-11-30 |
| 18057592610246 | icoone Laser Healthcare | I-TECH INDUSTRIES SRL | 2023-11-30 |
| 07290110122324 | Accent Prime UltraSpeed Applicator for Inc. | ALMA LASERS LTD. | 2022-11-22 |
| 07290110122317 | Accent Prime System 120V For Inc. | ALMA LASERS LTD. | 2022-11-22 |
| 07290016633702 | EmPowerRF platform | INMODE M.D LTD | 2022-10-25 |
| 07290016633658 | FormaI | INMODE M.D LTD | 2022-01-05 |
| 17290110122192 | Glide Disposable Tip (x1) | ALMA LASERS LTD. | 2021-11-14 |
| 17290110122185 | Opus Colibri 1mm Single-use Tip (X1) | ALMA LASERS LTD. | 2021-11-14 |
| 17290110122178 | Opus Colibri 0.7mm Single-use Tip (X1) | ALMA LASERS LTD. | 2021-11-14 |
| 17290110122161 | Opus Colibri 1mm Single-use Tip Set (X6) | ALMA LASERS LTD. | 2021-11-14 |
| 17290110122208 | Glide Disposable Tip Set (X12) | ALMA LASERS LTD. | 2021-11-14 |
| 17290110122154 | Opus Colibri 0.7mm Single-use Tip Set (X6) | ALMA LASERS LTD. | 2021-11-14 |
| 17290110122086 | Opus Plasma Applicator | ALMA LASERS LTD. | 2021-01-25 |
| 17290110121782 | Opus System 110V | ALMA LASERS LTD. | 2020-02-20 |
| 17290110121805 | Opus Plasma HP/Applicator | ALMA LASERS LTD. | 2020-02-17 |
| 17290110121775 | RF Pixel HP for Accent Elite System (110V) | ALMA LASERS LTD. | 2019-12-31 |
| 17290110121720 | Reform System | ALMA LASERS LTD. | 2019-05-06 |
| 17290110121706 | Inversa System | ALMA LASERS LTD. | 2019-04-08 |
| 17290110121713 | RF Pixel HP | ALMA LASERS LTD. | 2019-04-08 |
| 07290016746327 | BC Applicator | VIORA LTD | 2016-09-23 |
| 07290016746303 | Reaction™ | VIORA LTD | 2016-09-23 |
| 00816722021403 | truSculpt | CUTERA, INC. | 2016-09-23 |