Swiss LthoClast Trilogy— 510(k) K230893

Name: FDA 510(k) clearance K230893
Creator: U.S. Food and Drug Administration
Published: 2023-10-23

Substantially Equivalent

E.M.S Electro Medical Systems S.A

FDA 510(k) clearance K230893 for Swiss LthoClast Trilogy, Substantially Equivalent on 2023-10-23. Applicant: E.M.S Electro Medical Systems S.A. Device class: 2.

Clearance details

Applicant: E.M.S Electro Medical Systems S.A
Product code: Code FEO
Device class: Class 2
Regulation: 21 CFR 876.4480
Advisory panel: Gastroenterology, Urology
Date received: 2023-03-31
Decision date: 2023-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nyon, CH

Download summary PDF View on FDA.gov ↗

Recent devices under product code FEO

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K182490 — Swiss LithoClast Trilogy2018-10-09
K181997 — Swiss LithoClast Trilogy2018-08-30
K181364 — Swiss LithoClast Trilogy2018-06-20
K173234 — Swiss LithoClast Trilogy2018-01-10
K171024 — ShockPulse-SE Lithotripsy System2017-08-21

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K243279 — DOLORCLAST Focused Shock Waves2025-08-13
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K190124 — EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One2019-10-20
K191079 — Piezon Built-in Kit, Piezon Built-in Kit LED2019-08-16

Adverse events under product code FEO

product code FEO

Malfunction: 910
Other: 1
Total: 911

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.