K181896 is an FDA 510(k) clearance for the LIPOcel. This device is classified as a Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption (Class II - Special Controls, product code OHV).
Submitted by Jeisys Medical, Inc. (Seoul, KR). The FDA issued a Cleared decision on October 18, 2019, 459 days after receiving the submission on July 16, 2018.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4590. A Device Using Focused Ultrasound To Produce Localized, Mechanical Motion Within Tissues And Cells For The Purpose Of Producing Either Localized Heating For Tissue Coagulation Or For Mechanical Cellular Membrane Disruption Intended For Non-invasive Aesthetic Use..
| 510(k) Number | K181896 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 16, 2018 |
| Decision Date | October 18, 2019 |
| Days to Decision | 459 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | OHV - Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4590 |
| Definition | A Device Using Focused Ultrasound To Produce Localized, Mechanical Motion Within Tissues And Cells For The Purpose Of Producing Either Localized Heating For Tissue Coagulation Or For Mechanical Cellular Membrane Disruption Intended For Non-invasive Aesthetic Use. |