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510(k) K253396

AYON Body Contouring System™ (AYON SYSTEM) by Apyx Medical Corporation — Product Code QPB

K253396 is an FDA 510(k) premarket notification submitted by Apyx Medical Corporation for the device "AYON Body Contouring System™ (AYON SYSTEM)". The FDA issued a decision of Substantially Equivalent on May 8, 2026. The device falls under product code QPB (System, Suction, Lipoplasty For Removal), a Class II device regulated under 21 CFR 878.5040. Apyx Medical Corporation has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 2026
Date Received
September 30, 2025
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 Apyx Medical Corporation

  • K244050 — AYON Body Contouring System (AYON SYSTEM) (May 12, 2025)
  • K230586 — Renuvion® Micro Handpiece (June 9, 2023)
  • K230272 — Renuvion® APR Handpiece (April 27, 2023)
  • K223262 — Renuvion® APR Handpiece (February 23, 2023)
  • K221830 — Apyx One Console (October 11, 2022)

Other clearances for product code QPB

  • K251944 — Lipocosm Harmonic System (June 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)
  • 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)

FDA data resources