FDA device listing

AYON Body Contouring System™

FDA device listing 2026459369 · Apyx Medical Corporation

Key facts

Proprietary names AYON Body Contouring System™
Owner/operator Apyx Medical Corporation
Owner/operator number 9910100
Premarket submissions K253396
Product codes QPB
Device names QPB - System, Suction, Lipoplasty For Removal
Device class Class II
Classification regulations (21 CFR) 878.5040
Review panels General & Plastic Surgery
Registered establishments Apyx Medical Corporation
Establishment registrations 3007593903
FEI numbers 3007593903
Establishment operations Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 10–99 UDI devices (GUDID) under the same submission
  • 1–9 Device listings citing the same submission
  • Yes Premarket submission listed

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device listings

Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

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