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510(k) K242804

PAL Aspiration System by Microaire Surgical Instruments, LLC — Product Code QPB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 2024
Date Received
September 17, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Suction, Lipoplasty For Removal
Device Class
Class II
Regulation Number
878.5040
Review Panel
SU
Submission Type

A suction lipoplasty system is a device intended for the removal of adipose tissue for purposes of aesthetic body contouring

Other clearances by Microaire Surgical Instruments, LLC

  • K243589 — PAL Sterilization Case (June 20, 2025)
  • K244026 — PAL 7020 Console (April 25, 2025)
  • K223406 — SmartRelease Endoscopic Soft Tissue Release System (February 2, 2023)
  • K220318 — PAL Infiltration System (October 14, 2022)
  • K212024 — PAL System (June 10, 2022)
  • K211297 — SMARTRELEASE Endoscopic Soft Tissue Release System (June 24, 2021)
  • K192694 — PAL Single-Use Cannulas (May 14, 2020)
  • K181819 — SMARTRELEASE Endoscopic Soft Tissue Release System (November 6, 2018)
  • K171286 — PAL Multi-Use Cannulas and PAL Manual Wand (October 13, 2017)
  • K150779 — LipoFilter - Hospital Pack, LipoFilter - Clinic Pack (May 22, 2015)

Other clearances for product code QPB

  • K244050 — AYON Body Contouring System (AYON SYSTEM) (May 12, 2025)
  • K244026 — PAL 7020 Console (April 25, 2025)
  • K241835 — AirSculpt Body Contouring System (AIRS-1-SYS) (November 27, 2024)
  • K240188 — Vitruvian Liposaber (September 13, 2024)
  • K212969 — Liposaver (August 7, 2024)
  • K220318 — PAL Infiltration System (October 14, 2022)
  • K212024 — PAL System (June 10, 2022)
  • K192694 — PAL Single-Use Cannulas (May 14, 2020)
  • K200168 — Dermapose Access (April 22, 2020)
  • K190551 — VASERlipo System (May 1, 2019)