Product Classification

• Device: suction lipoplasty system for removal and transfer
• Regulation Description: Suction lipoplasty system.
• Definition: Removal and transfer/reimplantation of autologous adipose tissue without further manipulation for aesthetic body contouring
• Physical State: May include powered suction pump system, tubes, canisters, cannulas, syringes.
• Technical Method: Removal and transfer/reimplantation of autologous adipose tissue without further manipulation for aesthetic body contouring
• Target Area: Aesthetic body contouring of soft tissues
• Regulation Medical Specialty: General & Plastic Surgery
• Review Panel: General & Plastic Surgery
• Product Code: QUB
• Premarket Review: Center for Biologics Evaluation and Research Branch (CBER); CBER Division (CBER)
• 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

Third Party Review

Not Third Party Eligible