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U.S. Department of Health and Human Services

Product Classification
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Device system, suction, lipoplasty for removal
Regulation Description Suction lipoplasty system.
Definition A suction lipoplasty system is a device intended for the removal of adipose tissue for purposes of aesthetic body contouring
Physical State A suction lipoplasty system is a device intended for the removal of adipose tissue for purposes of aesthetic body contouring
Technical Method A suction lipoplasty system is a device intended for the removal of adipose tissue for purposes of aesthetic body contouring
Target Area Body
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeQPB
Premarket Review Office of Surgical and Infection Control Devices (OHT4)
Infection Control and Plastic and Reconstructive Surgery Devices (DHT4B)
Submission Type 510(k)
Regulation Number 878.5040
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
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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