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System, Ablation, Ultrasound And Accessories

FDA product code NTB · 6 cleared devices

Class 2 General, Plastic Surgery
Regulation
21 CFR 878.4400
Review panel
SU
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2004-02-26 – 2016-01-13

Intended for use as a surgical tool for coagulation and ablation of soft tissue. This differs from the description in the regulation in that this device is not intended to cut tissue and this device uses high intensity ultrasound energy instead of electrosurgery or electrocautery.

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