Cleared Traditional

K230893 - Swiss LthoClast Trilogy

K230893 is an FDA 510(k) clearance for Swiss LthoClast Trilogy, manufactured by E.M.S Electro Medical Systems S.A. The device is a Class 2 Gastroenterology & Urology device with product code FEO cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K230893 · E.M.S Electro Medical Systems S.A · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2023
Decision
206d
Days
Class 2
Risk

K230893 is an FDA 510(k) clearance for the Swiss LthoClast Trilogy. Classified as Lithotriptor, Ultrasonic (product code FEO), Class II - Special Controls.

Submitted by E.M.S Electro Medical Systems S.A (Nyon, CH). The FDA issued a Cleared decision on October 23, 2023 after a review of 206 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4480 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all E.M.S Electro Medical Systems S.A devices

FDA 510(k) Submission Details - K230893

510(k) Number K230893 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2023
Decision Date October 23, 2023
Days to Decision 206 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 131d · This submission: 206d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FEO Device Classification - Class 2, Special Controls

Product Code FEO Lithotriptor, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4480
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Consultant

Heyer Regulatory Solutions, LLC
Sheila Hemeon-Heyer

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FEO Lithotriptor, Ultrasonic

All 12
Devices cleared under the same product code (FEO) and FDA review panel - the closest regulatory comparables to K230893.
Swiss LithoClast Trilogy
K182490 · E.M.S Electro Medical Systems S.A · Oct 2018
Swiss LithoClast Trilogy
K181997 · E.M.S Electro Medical Systems S.A · Aug 2018
Swiss LithoClast Trilogy
K181364 · E.M.S Electro Medical Systems S.A · Jun 2018
Swiss LithoClast Trilogy
K173234 · E.M.S Electro Medical Systems S.A · Jan 2018
ShockPulse-SE Lithotripsy System
K171024 · Cybersonics, Inc. · Aug 2017
Shock Pulse-SE Lithotripsy System CYBERWAND II
K142428 · Cybersonics, Inc. · Nov 2014