Soniquence RF Generator and Soniquence Electrodes
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K183611 FDA 510(k)
- FDA Product Code
- GEI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4400 FDA 510(k)
- Regulation Number
- 878.4400 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Soniquence RF Generator is a compact electrosurgical unit that provides high-frequency RF energy for soft tissue cutting, coagulation, and hemostasis. The Soniquence Electrodes are intended for use by a physician familiar with resection, dissection, incision, and hemostasis in soft tissue surgical procedures. The SmoothWave generators operate at 4.0 MHz, which is over 8× higher than standard electrosurgical devices, minimizing lateral heat and protecting surrounding tissue.
The device is supplied as a system including the RF Generator and Electrodes. It is intended for use in soft tissue surgical procedures and operates at 4.0 MHz frequency. The device has received FDA 510(k) clearance with K number K183611 and is categorized under product code GEI. It is authorized for use in general and plastic surgery applications.
Frequently asked questions
What is the Soniquence RF Generator and Electrodes system used for?
The Soniquence RF Generator and Electrodes system is a compact electrosurgical unit that provides high-frequency RF energy for soft tissue cutting, coagulation, and hemostasis during surgical procedures. It operates at 4.0 MHz frequency, which is over 8× higher than standard electrosurgical devices, minimizing lateral heat and protecting surrounding tissue.
How is the Soniquence RF Generator and Electrodes system supplied?
The device is supplied as a complete system including both the RF Generator and the Soniquence Electrodes. It is intended for use by physicians familiar with resection, dissection, incision, and hemostasis in soft tissue surgical procedures, particularly in general and plastic surgery applications.
What regulatory approvals has the Soniquence system received?
The Soniquence RF Generator and Electrodes system has received FDA 510(k) clearance with K number K183611. It is categorized under product code GEI and is authorized for use in general and plastic surgery applications. The device was determined to be substantially equivalent to predicate devices.
How does the 4.0 MHz frequency of the Soniquence system benefit surgical procedures?
The 4.0 MHz frequency of the Soniquence system is over 8× higher than standard electrosurgical devices, which minimizes lateral heat spread and helps protect surrounding tissue during procedures. This higher frequency allows for more precise cutting and coagulation while reducing thermal damage to adjacent healthy tissue.
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: Soniquence - Precision Cutting & Bipolar Hemostasis, Soniquence RF Generator and Soniquence Electrodes (K183611) — FDA 510 ..., PDF Soniquence® Product Brochure www.soniquence.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K183611 | Class II | Active |
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Manufacturer
- Manufacturer
- Soniquence, LLC
Sources (1)
- FDA 510(k) K183611 24 fields · synced Sep 24, 2026