Regulation

FDA Final Order: Classification of Focused Ultrasound System for Non-Thermal, Mechanical Tissue Ablation (Class II)

Citation: 91 FR 63493 (Doc. 2026-20440)
Jurisdiction: U.S.
In force: 2026-10-06
Text: federalregister.gov/documents/2026/10/06/2026-20440/medical-devices-general-and-plastic-surgery-devices-classification-of-the-focused-ultrasound-system
Stories: 1

Healthcare

U.S. FEDRegulation

FDA classifies focused ultrasound tissue ablation system as class II device

Text (Federal Register) →Oct. 6