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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 K211652
Device Name Renuvion Dermal Handpiece, Renuvion Dermal System
Applicant
Apyx Medical Corporation (Formerly Bovie Medical Corporation
5115 Ulmerton Rd.
Clearwater,  FL  33760
Applicant Contact Topaz Kirlew
Correspondent
Apyx Medical Corporation (Formerly Bovie Medical Corporation
5115 Ulmerton Rd.
Clearwater,  FL  33760
Correspondent Contact Priscilla Herpai
Regulation Number878.4400
Classification Product Code
GEI  
Date Received05/28/2021
Decision Date 05/25/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT03286283
NCT04185909
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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