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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 K223262
Device Name Renuvion® APR Handpiece
Applicant
Apyx Medical Corporation
(Formerly Bovie Medical Corporation)
5115 Ulmerton Rd.
Clearwater,  FL  33760 -4004
Applicant Contact Mark D. Evans
Correspondent
Apyx Medical Corporation
(Formerly Bovie Medical Corporation)
5115 Ulmerton Rd.
Clearwater,  FL  33760 -4004
Correspondent Contact Mark D. Evans
Regulation Number878.4400
Classification Product Code
GEI  
Date Received10/24/2022
Decision Date 02/23/2023
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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