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510(k) K241835

AirSculpt Body Contouring System (AIRS-1-SYS) by Cellmyx — Product Code QPB

K241835 is an FDA 510(k) premarket notification submitted by Cellmyx for the device "AirSculpt Body Contouring System (AIRS-1-SYS)". The FDA issued a decision of Substantially Equivalent on November 27, 2024. The device falls under product code QPB (System, Suction, Lipoplasty For Removal), a Class II device regulated under 21 CFR 878.5040.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 2024
Date Received
June 25, 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 for product code QPB

  • K251944 — Lipocosm Harmonic System (June 8, 2026)
  • K253396 — AYON Body Contouring System™ (AYON SYSTEM) (May 8, 2026)
  • K252495 — LSSA (NP-200) (April 3, 2026)
  • K244050 — AYON Body Contouring System (AYON SYSTEM) (May 12, 2025)
  • K244026 — PAL 7020 Console (April 25, 2025)
  • K242804 — PAL Aspiration System (December 30, 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)

FDA data resources