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Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation

FDA product code QGM · 2 cleared devices

Class 2 General, Plastic Surgery
Regulation
21 CFR 878.4405
Review panel
SU
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2024-03-13 – 2024-10-30

This device uses focused ultrasound to mechanically ablate soft tissue. The device is not intended to thermally ablate tissue.

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