K182453 is an FDA 510(k) clearance for the ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER). This device is classified as a Massager, Vacuum, Light Induced Heating (Class II - Special Controls, product code NUV).
Submitted by I-Tech Industries Srl (San Lazzaro Di Savena, IT). The FDA issued a Cleared decision on January 11, 2019, 126 days after receiving the submission on September 7, 2018.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4810. The Device Is Intended To Temporarily Alter The Appearance Of Cellulite.
| 510(k) Number | K182453 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 07, 2018 |
| Decision Date | January 11, 2019 |
| Days to Decision | 126 days |
| Submission Type | Abbreviated |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | NUV - Massager, Vacuum, Light Induced Heating |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4810 |
| Definition | The Device Is Intended To Temporarily Alter The Appearance Of Cellulite |