DOLORCLAST Focused Shock Waves
FDA 510(k) clearance K243279 · decided 2025-08-13
Clearance details
- K-number
- K243279
- Device name
- DOLORCLAST Focused Shock Waves
- Applicant
- E.M.S Electro Medical Systems S.A
- Decision
- Substantially Equivalent
- Date received
- 2024-10-16
- Decision date
- 2025-08-13
- Days to decision
- 301 days
- Clearance type
- Traditional
- Product code
- PZL
- Device class
- 2
- Regulation number
- 878.4685
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Nyon, CH
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.