NUV · Massager, Vacuum, Light Induced Heating
General, Plastic Surgery · 21 CFR 878.4810 · Class 2
Overview
| Product Code | NUV |
|---|---|
| Device Name | Massager, Vacuum, Light Induced Heating |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| 3rd-Party Reviewable | Yes |
Identification
(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
Classification Rationale
(1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
Recent Cleared Devices (19 of 19)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K231092 | T-SHAPE 2 | B&M S.R.L. Marketing Nel Benessere | Sep 22, 2023 | SESE |
| K211272 | ICOONE Laser Med (also referred to as ICOONE Medical laser) | I-Tech Industries Srl | Jun 22, 2021 | SESE |
| K182453 | ICOONE h (also referred to as ICOONE LASER and ICOONE h LASER) | I-Tech Industries Srl | Jan 11, 2019 | SESE |
| K161892 | Slimming Treatment Device | Beijing Honkon Technologies Co., Ltd. | Mar 2, 2017 | SESE |
| K131362 | INMODE WMBODY DEVICE | Inmode MD , Ltd. | Oct 8, 2013 | SESE |
| K122579 | VELASHAPE | Syneron Medical, Ltd. | Sep 13, 2012 | SESE |
| K101147 | MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEM | Alma Lasers, Inc. | Jan 21, 2011 | SESE |
| K101366 | I-LIPO, MODELS A00-1238 (230V), A00-1239 (120V) | Chromogenex Technologies, Ltd. | Sep 17, 2010 | SESE |
| K100230 | SMOOTHSHAPES SYSTEM, 11318-120V, 11319-230V | Eleme Medical, Inc. | Apr 2, 2010 | SESE |
| K092195 | CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD) | Cutera, Inc. | Oct 1, 2009 | SESE |
| K090221 | REACTION SYSTEM | Viora , Ltd. | Jul 1, 2009 | SESE |
| K083629 | SMOOTHSHAPES | Eleme Medical, Inc. | Feb 19, 2009 | SESE |
| K082622 | ALMA LASERS ACCENT B-SHAPE MASSAGER HANDPIECE/MODULE | Alma Lasers , Ltd. | Jan 12, 2009 | SESE |
| K080300 | CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD) | Cutera, Inc. | Apr 8, 2008 | SESE |
| K071872 | VELASHAPE | Syneron Medical, Ltd. | Aug 22, 2007 | SESE |
| K070092 | MODIFICATION TO VELASMOOTH, SHAPER | Syneron Medical, Ltd. | Jul 27, 2007 | SESE |
| K061603 | SMOOTHSHAPES | Biocellulase, Inc. | Jul 3, 2006 | SESE |
| K053611 | SMOOTHSHAPES | Bicellulase, Inc. | Mar 15, 2006 | SESE |
| K050397 | VELASMOOTH, SHAPER | Syneron Medical, Ltd. | Jun 9, 2005 | SESE |
Top Applicants
- Syneron Medical, Ltd. — 4 clearances
- I-Tech Industries Srl — 2 clearances
- Eleme Medical, Inc. — 2 clearances
- Cutera, Inc. — 2 clearances
- Viora , Ltd. — 1 clearance
