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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K230272
Device Name Renuvion® APR Handpiece
Applicant
Apyx Medical Corporation
5115 Ulmerton Rd.
Clearwater,  FL  33760
Applicant Contact Angela Huber
Correspondent
Apyx Medical Corporation
5115 Ulmerton Rd.
Clearwater,  FL  33760
Correspondent Contact Angela Huber
Regulation Number878.4400
Classification Product Code
GEI  
Date Received01/31/2023
Decision Date 04/27/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT04146467
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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