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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 K202880
Device Name J-Plasma Precise FLEX Handpiece
Applicant
Apyx Medical Corporation (Formerly Bovie Medical Corporation
5115 Ulmerton Rd.
Clearwater,  FL  33760
Applicant Contact Lauren Tiller
Correspondent
Apyx Medical Corporation (Formerly Bovie Medical Corporation
5115 Ulmerton Rd.
Clearwater,  FL  33760
Correspondent Contact Topaz Kirlew
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/28/2020
Decision Date 01/04/2021
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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