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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 K221830
Device Name Apyx One Console
Applicant
Apyx Medical Corporation
5115 Ulmerton Rd.
Clearwater,  FL  33760
Applicant Contact David Ceretti
Correspondent
Apyx Medical Corporation
5115 Ulmerton Rd.
Clearwater,  FL  33760
Correspondent Contact David Ceretti
Regulation Number878.4400
Classification Product Code
GEI  
Date Received06/23/2022
Decision Date 10/11/2022
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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