K232455 is an FDA 510(k) clearance for the SofWave System. This device is classified as a Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption (Class II - Special Controls, product code OHV).
Submitted by Sofwave Medical, Ltd. (Yokneam Iiit, IL). The FDA issued a Cleared decision on December 14, 2023, 122 days after receiving the submission on August 14, 2023.
This device falls under the Physical Medicine 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 | K232455 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 14, 2023 |
| Decision Date | December 14, 2023 |
| Days to Decision | 122 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| 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. |