Product Classification

• Device: system, suction, lipoplasty
• Regulation Description: Suction lipoplasty system.
• Definition: See Federal Register Notice at 86 FR 50887 “Consolidation of Devices That Process Autologous Human Cells, Tissues, and Cellular and Tissue-Based Products at the Point of Care to Produce a Therapeutic Article” (FRN) (FDA-2021-N-0881).
• Regulation Medical Specialty: General & Plastic Surgery
• Review Panel: General & Plastic Surgery
• Product Code: MUU
• 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: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 1-155 ISO 10079-2 Fourth edition 2022-03
  Medical suction equipment - Part 2: Manually powered suction equipment
• 1-156 ISO 10079-3 Fourth edition 2022-03
  Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source
• 1-157 ISO 10079-1 Fourth edition 2022-03
  Medical suction equipment - Part 1: Electrically powered suction equipment
• 1-158 ISO 10079-4 First edition 2021-08
  Medical suction equipment - Part 4: General requirements

Third Party Review

Not Third Party Eligible