510(k) K230820
K230820 is an FDA 510(k) premarket notification submitted by Sofwave Medical, Ltd. for the device "SofWave System". The FDA issued a decision of Substantially Equivalent on April 18, 2023. The device falls under product code OHV (Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption), a Class II device regulated under 21 CFR 878.4590. Sofwave Medical, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 18, 2023
- Date Received
- March 24, 2023
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
- Device Class
- Class II
- Regulation Number
- 878.4590
- Review Panel
- SU
- Submission Type
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.