www.fdanews.com/articles/197359-gynesonics-sonata-system-21-gets-green-light
Gynesonics’ Sonata System 2.1 Gets Green Light
June 1, 2020
Gynesonics has earned 510(k) clearance from the FDA for its next-generation Sonata System 2.1 for ablating symptomatic uterine fibroids.
The platform combines ultrasound with an advanced radio-frequency ablation device, allowing for incisionless, transcervical treatment of fibroids in the uterus.
The new version of the Sonata system includes a smaller, more efficient radio-frequency ablation handpiece with improved controls.