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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Suction, Lipoplasty For Removal
510(k) Number K253396
Device Name AYON Body Contouring System™ (AYON SYSTEM)
Applicant
Apyx Medical Corporation
5115 Ulmerton Rd.
Clearwater,  FL  33760
Applicant Contact Nikita Gajbhiye
Correspondent
Apyx Medical Corporation
5115 Ulmerton Rd.
Clearwater,  FL  33760
Correspondent Contact Nikita Gajbhiye
Regulation Number878.5040
Classification Product Code
QPB  
Date Received09/30/2025
Decision Date 05/08/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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