Holmium Laser System - Holmium Laser System (Potent HP150)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K252771 FDA 510(k)
- FDA Product Code
- GEX FDA 510(k)
- Models / Variants
- Holmium Laser System (Potent HP150) FDA 510(k)EUDAMED
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Holmium Laser System (Potent HP Series) is a pulsed solid-state Holmium:YAG laser device designed for soft tissue surgery and stone fragmentation. Operating at a wavelength of 2100 nm, it employs a flashlamp-pumped laser medium with energy delivery via SMA905-compatible optical fibers. This system is classified as a surgical laser under the General, Plastic Surgery advisory committee category.
The device is intended for use in clinical settings, including operating rooms and outpatient clinics, and is supplied with a touchscreen interface and dual-pedal footswitch. It features fiber auto-recognition and is regulated under FDA 510(k) clearance (Substantially Equivalent) and MDR. The systems are reusable and not specified as sterile or MRI-safe; storage and handling follow standard laser device protocols.
Frequently asked questions
What clinical applications is the Holmium Laser System (Potent HP Series) primarily designed for?
The Holmium Laser System (Potent HP Series) is designed for soft tissue surgery and stone fragmentation, leveraging its 2100 nm wavelength to effectively cut, coagulate, and vaporize tissue while breaking down calculi (stones). This makes it suitable for procedures in urology, gynecology, and general surgery where precise tissue manipulation or stone removal is required.
How is the Holmium Laser System (Potent HP Series) powered and controlled during use?
The system features a touchscreen interface for user control and includes dual-pedal footswitches for hands-free operation, allowing clinicians to adjust settings while maintaining precision. Energy is delivered via SMA905-compatible optical fibers, which are auto-recognized by the device for seamless integration.
Are the Holmium Laser System (Potent HP Series) models reusable, and what considerations should be taken for maintenance?
Yes, the Holmium Laser System (Potent HP Series) is designed as a reusable device. Like all laser systems, it requires adherence to manufacturer guidelines for cleaning, calibration, and maintenance to ensure optimal performance and safety. Standard laser device protocols—including proper storage, handling, and periodic servicing—should be followed to prevent degradation or contamination.
What regulatory pathways have been followed for the Holmium Laser System (Potent HP Series), and how does this affect its use?
The device has undergone FDA 510(k) clearance under the Traditional pathway, determined to be *Substantially Equivalent* to a predicate device, and complies with the EU Medical Device Regulation (MDR). This means it meets U.S. and EU safety and performance standards for surgical lasers, though clinicians should always refer to local regulatory guidelines and institutional policies for specific use cases.
What fiber compatibility and connectivity options are available with the Holmium Laser System (Potent HP Series)?
The system is compatible with SMA905 optical fibers, a standard connector type used in many laser applications. This compatibility ensures flexibility in choosing fibers for different clinical procedures, though the specific fiber types (e.g., delivery length, tip design) should be selected based on the intended surgical application and manufacturer recommendations.
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: Holmium – Wikipedia, Holmium Laser System (Potent HP90); Holmium Laser System (Potent HP100 ..., Holmium Laser HP Series - Potent Medical
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K252771 | Class II | Active |
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Manufacturer
Sources (2)
- FDA 510(k) K252771 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced Jun 18, 2026