Massager, Vacuum, Light Induced Heating
The Vacuum and Light-Induced Heating Massager is a cosmetic device intended to temporarily alter the appearance of cellulite by combining vacuum suction and light-induced heating to manipulate superficial tissue. It is an FDA Class 2 device regulated under 21 CFR 878.4810 in the General and Plastic Surgery specialty, with product code NUV, requiring 510(k) clearance. Third-party review is available. It is not an implant and does not carry life-sustaining support designation.
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Basic Information
- Product Code
- NUV
- Device Class
- FDA class 2
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
Definition
The device is intended to temporarily alter the appearance of cellulite
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 19 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K231092 | T-SHAPE 2 | Sep 22, 2023 | Substantially Equivalent | B&M S.R.L. Marketing Nel Benessere |
| K211272 | ICOONE Laser Med (also referred to as ICOONE Medical laser) | Jun 22, 2021 | Substantially Equivalent | I-Tech Industries Srl |
| K182453 | ICOONE h (also referred to as ICOONE LASER and ICOONE h LASER) | Jan 11, 2019 | Substantially Equivalent | I-Tech Industries Srl |
| K161892 | Slimming Treatment Device | Mar 02, 2017 | Substantially Equivalent | Beijing Honkon Technologies Co., Ltd. |
| K131362 | INMODE WMBODY DEVICE | Oct 08, 2013 | Substantially Equivalent | Inmode MD , Ltd. |
| K122579 | VELASHAPE | Sep 13, 2012 | Substantially Equivalent | Syneron Medical, Ltd. |
| K101147 | MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEM | Jan 21, 2011 | Substantially Equivalent | Alma Lasers, Inc. |
| K101366 | I-LIPO, MODELS A00-1238 (230V), A00-1239 (120V) | Sep 17, 2010 | Substantially Equivalent | Chromogenex Technologies, Ltd. |
| K100230 | SMOOTHSHAPES SYSTEM, 11318-120V, 11319-230V | Apr 02, 2010 | Substantially Equivalent | Eleme Medical, Inc. |
| K092195 | CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD) | Oct 01, 2009 | Substantially Equivalent | Cutera, Inc. |
| K090221 | REACTION SYSTEM | Jul 01, 2009 | Substantially Equivalent | Viora , Ltd. |
| K083629 | SMOOTHSHAPES | Feb 19, 2009 | Substantially Equivalent | Eleme Medical, Inc. |
| K082622 | ALMA LASERS ACCENT B-SHAPE MASSAGER HANDPIECE/MODULE | Jan 12, 2009 | Substantially Equivalent | Alma Lasers , Ltd. |
| K080300 | CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD) | Apr 08, 2008 | Substantially Equivalent | Cutera, Inc. |
| K071872 | VELASHAPE | Aug 22, 2007 | Substantially Equivalent | Syneron Medical, Ltd. |
| K070092 | MODIFICATION TO VELASMOOTH, SHAPER | Jul 27, 2007 | Substantially Equivalent | Syneron Medical, Ltd. |
| K061603 | SMOOTHSHAPES | Jul 03, 2006 | Substantially Equivalent | Biocellulase, Inc. |
| K053611 | SMOOTHSHAPES | Mar 15, 2006 | Substantially Equivalent | Bicellulase, Inc. |
| K050397 | VELASMOOTH, SHAPER | Jun 09, 2005 | Substantially Equivalent | Syneron Medical, Ltd. |
FEI Numbers
This FDA classification entry is associated with 20 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 20 registration numbers. Click on an entry to view related FDA registrations.