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Swiss LithoClast Trilogy

by E.M.S. Electro Medical Systems S.A. Switzerland 510(k)

510(k) K173234 Product code FEO

Overview

The Swiss LithoClast Trilogy Lithotripter is an ultrasonic lithotripter designed for the fragmentation of urinary and biliary stones. Classified as a lithotriptor under FDA product code FEO, it operates using high-intensity focused ultrasound to shatter calcified deposits in the urinary tract, gallbladder, or bile ducts without invasive surgical intervention. Its dual-energy capability allows for effective treatment of diverse stone compositions, including calcium phosphate and calcium oxalate. This device is intended for use in urology and gastroenterology procedures, where precision and efficiency in stone fragmentation are critical.

The Swiss LithoClast Trilogy Lithotripter is supplied as a reusable medical device, requiring proper sterilization between uses in accordance with regulatory guidelines. It is classified as a Class II device under FDA regulations (21 CFR 876.4480) and has received 510(k) clearance from the FDA, demonstrating substantial equivalence to a predicate device. The system includes a handpiece, control unit, and foot pedal, with specific models and reference codes listed in the FDA registration. Storage and handling must comply with manufacturer instructions to maintain device integrity and performance, ensuring safe and effective clinical use in MRI-safe environments as specified for its intended applications.

Summary written by AI from registry data, 20 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK173234 Date10 Jan 2018ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
FEO
FDA applicant
E.M.S Electro Medical Systems S.A
Device Class
Class II
Regulation
21 CFR Part 876.4480
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Other devices from E.M.S. Electro Medical Systems S.A.

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Questions

  • What types of stones can the Swiss LithoClast Trilogy effectively break apart, and how does its dual-energy capability help in treatment?

    The Swiss LithoClast Trilogy is designed to fragment urinary and biliary stones, including common compositions like calcium phosphate and calcium oxalate. Its dual-energy capability allows clinicians to adjust the ultrasound settings for optimal fragmentation of different stone types, improving treatment efficacy and adaptability for diverse clinical cases.

  • Is the Swiss LithoClast Trilogy intended for use in MRI environments, and what considerations should clinicians keep in mind?

    Yes, the Swiss LithoClast Trilogy is specified for use in MRI-safe environments, meaning it can be operated safely alongside MRI procedures. Clinicians should follow the manufacturer’s instructions for storage, handling, and sterilization to ensure device integrity and performance, particularly when transitioning between MRI and non-MRI settings.

  • How is the Swiss LithoClast Trilogy supplied, and what sterilization requirements apply between uses?

    The Swiss LithoClast Trilogy is supplied as a reusable medical device, consisting of a handpiece, control unit, and foot pedal. Between uses, it must undergo proper sterilization as per regulatory guidelines to maintain safety and functionality, ensuring compliance with manufacturer recommendations for maintenance.

  • What medical specialties primarily use the Swiss LithoClast Trilogy, and why is it relevant to those fields?

    The Swiss LithoClast Trilogy is primarily used in urology and gastroenterology procedures, where precise fragmentation of urinary and biliary stones is critical. Its non-invasive ultrasound technology avoids surgical intervention, making it a valuable tool for treating kidney, bladder, gallbladder, and bile duct stones in these specialties.

  • Are there multiple models or reference codes for the Swiss LithoClast Trilogy, and how might this affect procurement or inventory management?

    Yes, the Swiss LithoClast Trilogy includes multiple models and reference codes (e.g., 3006546082, 3006617533, etc.), as listed in FDA registrations. This variety may allow for customization based on clinical needs or facility requirements, but it also necessitates careful inventory tracking to ensure the correct parts and accessories are available for maintenance and use.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K173234 24 fields · synced 22 Oct 2026