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U.S. Department of Health and Human Services

Product Classification

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Device lipoaspirate washing system for aesthetic body contouring
Regulation Description Suction lipoplasty system.
Definition Wash, filter, concentrate, and or fragment autologous adipose tissue aspirated via liposuction for aesthetic body contouring without further manipulation
Physical State May include filter, sieve, canister, non-enzymatic wash solution, non-suctioning. The system should be used with a legally-marketed vacuum or aspirator apparatus as a source of suction. Should not use enzymatic digestion or cell selection.
Technical Method Aspirated fat is washed, cleansed, and/or rinsed without further processing/manipulation such as cell selection or enzymatic digestion.
Target Area Aesthetic body contouring of soft tissues
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeQKL
Premarket Review Center for Biologics Evaluation & Research (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
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible