Velashape
FDA 510(k) K122579 · Syneron Medical, Ltd.
510(k) numberK122579
Submission
- Device name
- Velashape
- Applicant
- Syneron Medical, Ltd.
Yokneam, Illit, IL - Received
- August 23, 2012
- Decision date
- September 13, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NUV – Massager, Vacuum, Light Induced Heating
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4810
- Specialty
- General, Plastic Surgery
The device is intended to temporarily alter the appearance of cellulite
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|---|---|---|---|
| K261582 | Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02)NUV · Traditional | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 08/28/2026SE |
| K231092 | T-Shape 2NUV · Traditional | B&M S.R.L. Marketing Nel Benessere | 09/22/2023SE |
| K211272 | ICOONE Laser Med (also referred to as ICOONE Medical laser)NUV · Traditional | I-Tech Industries Srl | 06/22/2021SE |
| K182453 | ICOONE h (also referred to as ICOONE LASER and ICOONE h LASER)NUV · Abbreviated | I-Tech Industries Srl | 01/11/2019SE |
| K161892 | Slimming Treatment DeviceNUV · Traditional | Beijing Honkon Technologies Co., Ltd. | 03/02/2017SE |
| K131362 | Inmode Wmbody DeviceNUV · Traditional | Inmode MD , Ltd. | 10/08/2013SE |
| K101147 | Modified Alma Lasers Family of Accent Radiofrequency (RF) SystemNUV · Traditional | Alma Lasers, Inc. | 01/21/2011SE |
| K101366 | I-Lipo, Models A00-1238 (230V), A00-1239 (120V)NUV · Traditional | Chromogenex Technologies, Ltd. | 09/17/2010SE |
| K100230 | Smoothshapes System, 11318-120V, 11319-230VNUV · Special | Eleme Medical, Inc. | 04/02/2010SE |
| K092195 | Cutera Multimodal Cellulite Product (Cmmcd)NUV · Special | Cutera, Inc. | 10/01/2009SE |
More from Cutera, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K170370 | Ultrashape Power SystemOHV · Traditional | 05/15/2017SE |
| K163415 | SlimShape SystemGEI · Traditional | 04/20/2017SE |
| K162163 | UltraShape SystemOHV · Traditional | 11/17/2016SE |
| K161952 | UltraShape SystemOHV · Traditional | 11/07/2016SE |
| K160896 | Ultrashape Power SystemOHV · Traditional | 07/08/2016SE |
| K151655 | CO2RE SystemGEX · Traditional | 09/15/2015SE |
| K141507 | Two Skin Treatment SystemGEI · Traditional | 12/08/2014SE |
| K141708 | Ultrashape SystemOHV · Traditional | 10/06/2014SE |
| K133238 | Contour I V3.1 SystemOHV · Traditional | 04/10/2014SE |
| K120510 | TranscendGEI · Traditional | 07/19/2013SE |
Questions and answers
When was Velashape cleared by the FDA?
Velashape (K122579) received a 510(k) decision of Substantially Equivalent on September 13, 2012, 21 days after the submission was received.
What is the product code of K122579?
The FDA product code is NUV – Massager, Vacuum, Light Induced Heating, a Class II (moderate risk) device regulated under 21 CFR 878.4810.