ICOONE Laser Med (also referred to as ICOONE Medical laser)
FDA 510(k) K211272 · I-Tech Industries Srl
510(k) numberK211272
Submission
- Device name
- ICOONE Laser Med (also referred to as ICOONE Medical laser)
- Applicant
- I-Tech Industries Srl
Bergamo, IT - Received
- April 27, 2021
- Decision date
- June 22, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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
Other 510(k)s with product code NUV
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| 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 |
| K122579 | VelashapeNUV · Special | Syneron Medical, Ltd. | 09/13/2012SE |
| 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.
Questions and answers
When was ICOONE Laser Med (also referred to as ICOONE Medical laser) cleared by the FDA?
ICOONE Laser Med (also referred to as ICOONE Medical laser) (K211272) received a 510(k) decision of Substantially Equivalent on June 22, 2021, 56 days after the submission was received.
What is the product code of K211272?
The FDA product code is NUV – Massager, Vacuum, Light Induced Heating, a Class II (moderate risk) device regulated under 21 CFR 878.4810.