Soniquence, LLC - FDA 510(k) Cleared Devices

Soniquence, LLC develops radiofrequency surgical technology for medical, dental, and veterinary practices. The company operates with a manufacturing facility in Baldwin, US. Soniquence specializes in high-frequency surgical devices utilizing patented 4.0 MHz and 1.7 MHz radiofrequency technology for precision cutting and hemostasis.

The company has received 6 FDA 510(k) clearances from 6 total submissions. All submissions focus on General & Plastic Surgery devices. First clearance: 2019. Latest clearance: 2026. The company remains active in FDA regulatory submissions.

Soniquence's cleared device portfolio includes RF generators, bipolar electrodes, reusable surgical accessories, and fingerswitch wands. The SmoothWave i200 and i100 generator units operate at frequencies 8× higher than standard electrosurgical devices, minimizing lateral heat and protecting surrounding tissue. Products support faster procedures, improved healing, and reduced complications in surgical applications.

Explore the complete list of device names, product codes, and individual clearance dates in the 510(k) database.