Therasonic Lithotripsy Treatment System
FDA PMAClass II (US FDA PMA)
Identity
- Trade Name
- THERASONIC LITHOTRIPSY TREATMENT SYSTEM FDA PMA
- Generic Name
- Lithotriptor, extracorporeal shock-wave, urological FDA PMA
Identifiers
- PMA Number
- P890066 FDA PMA
- FDA Product Code
- LNS FDA PMA
Classification
- Device Class
- Class II FDA PMA
- Legislation / Framework
- 21 CFR Part 876.5990 FDA PMA
- Regulation Number
- 876.5990 FDA PMA
- Advisory Committee
- Gastroenterology, Urology FDA PMA
- FDA Decision
- APWD FDA PMA
The Therasonic Lithotripsy Treatment System is an extracorporeal shock-wave lithotriptor, classified as a urological device under the nomenclature authority. It generates high-energy shock waves to fragment and disintegrate urinary or biliary calculi (stones) non-invasively, facilitating their subsequent passage or removal from the body.
This system is intended for use in clinical settings by trained medical personnel, typically in urology or gastroenterology departments. It is supplied as a reusable medical device, with regulatory approval under an FDA Premarket Approval (PMA) (P890066). The device operates under the classification of Class II (LNS product code) and adheres to regulatory requirements outlined in 21 CFR 876.5990. No specific sterility or single-use designation is indicated in the data.
Frequently asked questions
What types of stones can the Therasonic Lithotripsy Treatment System treat, and how does it work?
The Therasonic Lithotripsy Treatment System is designed to treat urinary or biliary calculi (stones) by generating high-energy shock waves externally. These shock waves fragment and disintegrate the stones non-invasively, allowing them to be passed or removed from the body more easily. It is specifically intended for use in clinical settings by trained medical personnel, such as urologists or gastroenterologists.
Is the Therasonic Lithotripsy Treatment System a single-use device, or can it be reused?
The Therasonic Lithotripsy Treatment System is supplied as a reusable medical device. There is no indication in the provided data that it requires single-use or sterility beyond standard reusable medical device protocols, so it is intended for repeated use in a clinical environment.
What regulatory approval does the Therasonic Lithotripsy Treatment System hold, and how was it classified?
The Therasonic Lithotripsy Treatment System holds FDA Premarket Approval (PMA) under the number P890066. It is classified as a Class II device under the product code LNS (Lithotriptor, Extracorporeal Shock-Wave, Urological) and adheres to regulatory requirements outlined in 21 CFR 876.5990.
What medical specialties are primarily associated with the use of this device?
The Therasonic Lithotripsy Treatment System is primarily associated with the medical specialties of urology and gastroenterology, as indicated by its advisory committee designation (GU) and the medical specialty description provided in the data.
This description and any FAQs above were generated automatically from registry data 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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P890066 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Focus Surgery, Inc.
Sources (1)
- FDA PMA P890066 23 fields · synced Sep 18, 2026