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FDA 510(k)

DOLORCLAST Focused Shock Waves

K-Number: K243279 · 2025-08-13

ApplicantE.M.S Electro Medical Systems S.A
Decision Date2025-08-13
Product CodePZL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DOLORCLAST Focused Shock Waves is the device name listed in this FDA 510(k) record. The listed applicant is E.M.S Electro Medical Systems S.A. It received FDA 510(k) clearance on 2025-08-13 under 510(k) number K243279. The device is classified under product code PZL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DOLORCLAST Focused Shock Waves?

DOLORCLAST Focused Shock Waves is a medical device that received FDA 510(k) clearance on 2025-08-13. The listed applicant is E.M.S Electro Medical Systems S.A. The 510(k) number is K243279.

When did DOLORCLAST Focused Shock Waves receive FDA 510(k) clearance?

DOLORCLAST Focused Shock Waves received FDA 510(k) clearance on 2025-08-13, under 510(k) number K243279.

Who is the listed applicant for DOLORCLAST Focused Shock Waves?

The FDA 510(k) record lists E.M.S Electro Medical Systems S.A as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DOLORCLAST Focused Shock Waves?

The FDA product code for DOLORCLAST Focused Shock Waves is PZL.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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