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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 K261710
Device Name AYON™ Power Liposuction Cannulas and AYON™ Power Liposuction Cannula Adaptors
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 Received05/22/2026
Decision Date 08/21/2026
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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