Medical Device Manufacturer · US , Clearwater , FL

Apyx Medical Corporation - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2022

Recent clearances: AYON Body Contouring System™ (AYON SYSTEM), AYON Body Contouring System (AYON SYSTEM), Renuvion® Micro Handpiece

6

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - Apyx Medical Corporation General & Plastic Surgery ✕

6 devices

1-6 of 6

Cleared May 08, 2026

AYON Body Contouring System™ (AYON SYSTEM)

General & Plastic Surgery · 220d

Cleared May 12, 2025

AYON Body Contouring System (AYON SYSTEM)

General & Plastic Surgery · 132d

Cleared Jun 09, 2023

Renuvion® Micro Handpiece

General & Plastic Surgery · 99d

Cleared Apr 27, 2023

Renuvion® APR Handpiece

General & Plastic Surgery · 86d

Cleared Feb 23, 2023

Renuvion® APR Handpiece

General & Plastic Surgery · 122d

Cleared Oct 11, 2022

Apyx One Console

General & Plastic Surgery · 110d