DOLORCLAST Focused Shock Waves

FDA 510(k) K243279 · E.M.S Electro Medical Systems S.A

Substantially Equivalent

510(k) numberK243279

Submission

Device name
DOLORCLAST Focused Shock Waves
Applicant
E.M.S Electro Medical Systems S.A
Nyon, CH
Received
October 16, 2024
Decision date
August 13, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
PZL – Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4685
Specialty
General, Plastic Surgery

Treatment of diabetic foot ulcers

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Questions and answers

When was DOLORCLAST Focused Shock Waves cleared by the FDA?

DOLORCLAST Focused Shock Waves (K243279) received a 510(k) decision of Substantially Equivalent on August 13, 2025, 301 days after the submission was received.

What is the product code of K243279?

The FDA product code is PZL – Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers, a Class II (moderate risk) device regulated under 21 CFR 878.4685.