• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification

  • Print
  • Share
  • E-mail
-
New Search Back to Search Results
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 Surgical and Infection Control Devices (OHT4)
Infection Control and Plastic 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
-
-