Identity
- Trade Name
- DORNIER LITHOTRIPTER COMPACT TRANSPORTABLE (DLCT) FDA PMA
- Generic Name
- Lithotriptor, extracorporeal shock-wave, urological FDA PMA
Identifiers
- PMA Number
- P840008 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
- APRL FDA PMA
The Dornier Lithotripter HM3 is an extracorporeal shock-wave lithotriptor, urological, designed to fragment urinary stones using high-energy shock waves generated outside the body. This device operates on the principle of lithotripsy, delivering focused acoustic waves to break renal or ureteral calculi into smaller fragments for easier passage or subsequent removal.
The HM3 is intended for use in clinical settings such as urology and gastroenterology departments, where it is employed under sterile conditions for single-patient procedures. Supplied as a reusable medical device, it requires proper maintenance and calibration to ensure accuracy and safety. Authorized under FDA_PMA (P840008), the device adheres to regulatory standards for extracorporeal lithotripsy systems, with classification as a Class II medical device under 21 CFR 876.5990.
Frequently asked questions
What clinical specialties primarily use the Dornier Lithotripter HM3, and why is it relevant to those fields?
The Dornier Lithotripter HM3 is primarily used in urology and gastroenterology departments. It is relevant to these fields because it is designed to fragment urinary stones—such as renal or ureteral calculi—using extracorporeal shock waves. This non-invasive procedure helps patients avoid surgical interventions by breaking stones into smaller fragments that can pass naturally or be more easily removed, making it a key tool for managing urinary tract obstructions.
Is the Dornier Lithotripter HM3 a single-use or reusable device, and what maintenance is required?
The Dornier Lithotripter HM3 is a reusable medical device. Since it is intended for single-patient procedures under sterile conditions, it must undergo proper maintenance and calibration between uses to ensure accuracy, safety, and performance. Regular servicing is essential to comply with regulatory standards and maintain its functionality for repeated clinical applications.
What regulatory pathway was followed for the approval of this device, and what classification does it hold?
The Dornier Lithotripter HM3 was authorized through the FDA’s Premarket Approval (PMA) process, with the approval number P840008. It is classified as a Class II medical device under 21 CFR 876.5990, which reflects its role as an extracorporeal shock-wave lithotriptor used for urological procedures. This classification indicates it undergoes stricter regulatory oversight due to its intended use in breaking urinary stones.
How is the Dornier Lithotripter HM3 different from the Dornier Lithotripter Compact Transportable (DLCT)?
The Dornier Lithotripter HM3 is the primary model described, while the Dornier Lithotripter Compact Transportable (DLCT) appears as a trade name variant. Both are likely part of the same family of extracorporeal shock-wave lithotriptors, but the DLCT suggests a design optimized for portability or space efficiency. The HM3 is explicitly detailed as a reusable lithotriptor for clinical use in urology and gastroenterology, whereas the DLCT may offer additional features like mobility without altering the core function of stone fragmentation.
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. Sources consulted: Dornier MedTech - A Leading Urological Medical Device Company
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P840008 | Class II | Active |
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Manufacturer
- Manufacturer
- Dornier MedTech America, Inc.
Sources (1)
- FDA PMA P840008 24 fields · synced Oct 6, 2026