Clearance Summary
DOLORCLAST Focused Shock Waves received FDA 510(k) clearance under submission number K243279, sponsored by E.M.S Electro Medical Systems S.A. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2025-08-13.
- Submission: K243279
- Applicant / Sponsor: E.M.S Electro Medical Systems S.A
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4685
- Decision date: 2025-08-13
Classification & Regulation
This clearance is catalogued under FDA product code PZL and 21 CFR 878.4685, within the General, Plastic Surgery review panel as a Class II device.