Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation
- US Product Code (FDA)
- QGMView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 878.4405View CFR Regulation →
- Medical specialty
- General, Plastic Surgery
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
This device uses focused ultrasound to mechanically ablate soft tissue. The device is not intended to thermally ablate tissue.
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Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation is a medical device type in the General, Plastic Surgery specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.