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U.S. Department of Health and Human Services

Product Classification
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Device focused ultrasound system for non-thermal, mechanical tissue ablation
Definition This device uses focused ultrasound to mechanically ablate soft tissue. The device is not intended to thermally ablate tissue.
Physical State Ultrasound system and system accessories
Technical Method Cavitation is induced by non-invasive focused ultrasound which creates very high pressure points.
Target Area Various body cavities and organs
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeQGM
Premarket Review General Surgery Devices (DHT4A)
General Surgery Devices (DHT4A)
Submission Type 510(k)
Regulation Number 878.4405
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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