Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4810](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4810) → NUV — Massager, Vacuum, Light Induced Heating # NUV · Massager, Vacuum, Light Induced Heating _General, Plastic Surgery · 21 CFR 878.4810 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NUV ## Overview - **Product Code:** NUV - **Device Name:** Massager, Vacuum, Light Induced Heating - **Regulation:** [21 CFR 878.4810](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4810) - **Device Class:** 2 - **Review Panel:** [General, Plastic Surgery](/submissions/SU) - **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](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NUV/K231092.md) | T-SHAPE 2 | B&M S.R.L. Marketing Nel Benessere | Sep 22, 2023 | SESE | | [K211272](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NUV/K211272.md) | ICOONE Laser Med (also referred to as ICOONE Medical laser) | I-Tech Industries Srl | Jun 22, 2021 | SESE | | [K182453](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NUV/K182453.md) | ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER) | I-Tech Industries Srl | Jan 11, 2019 | SESE | | [K161892](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NUV/K161892.md) | Slimming Treatment Device | Beijing Honkon Technologies Co., Ltd. | Mar 2, 2017 | SESE | | [K131362](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NUV/K131362.md) | INMODE WMBODY DEVICE | Inmode MD , Ltd. | Oct 8, 2013 | SESE | | [K122579](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NUV/K122579.md) | VELASHAPE | Syneron Medical, Ltd. | Sep 13, 2012 | SESE | | [K101147](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NUV/K101147.md) | MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEM | Alma Lasers, Inc. | Jan 21, 2011 | SESE | | [K101366](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NUV/K101366.md) | I-LIPO, MODELS A00-1238 (230V), A00-1239 (120V) | Chromogenex Technologies, Ltd. | Sep 17, 2010 | SESE | | [K100230](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NUV/K100230.md) | SMOOTHSHAPES SYSTEM, 11318-120V, 11319-230V | Eleme Medical, Inc. | Apr 2, 2010 | SESE | | [K092195](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NUV/K092195.md) | CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD) | Cutera, Inc. | Oct 1, 2009 | SESE | | [K090221](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NUV/K090221.md) | REACTION SYSTEM | Viora , Ltd. | Jul 1, 2009 | SESE | | [K083629](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NUV/K083629.md) | SMOOTHSHAPES | Eleme Medical, Inc. | Feb 19, 2009 | SESE | | [K082622](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NUV/K082622.md) | ALMA LASERS ACCENT B-SHAPE MASSAGER HANDPIECE/MODULE | Alma Lasers , Ltd. | Jan 12, 2009 | SESE | | [K080300](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NUV/K080300.md) | CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD) | Cutera, Inc. | Apr 8, 2008 | SESE | | [K071872](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NUV/K071872.md) | VELASHAPE | Syneron Medical, Ltd. | Aug 22, 2007 | SESE | | [K070092](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NUV/K070092.md) | MODIFICATION TO VELASMOOTH, SHAPER | Syneron Medical, Ltd. | Jul 27, 2007 | SESE | | [K061603](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NUV/K061603.md) | SMOOTHSHAPES | Biocellulase, Inc. | Jul 3, 2006 | SESE | | [K053611](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NUV/K053611.md) | SMOOTHSHAPES | Bicellulase, Inc. | Mar 15, 2006 | SESE | | [K050397](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NUV/K050397.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NUV](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NUV) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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