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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 autologous adipose tissue aspirated via liposuction for aesthetic body contouring without further processing/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
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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