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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 K202106
Device Name Plasmage System
Applicant
Brera Medical Inc
19 Kramas Lane
Northwood,  NH  03261
Applicant Contact Felix Feldchtein
Correspondent
Brera Medical Inc
19 Kramas Lane
Northwood,  NH  03261
Correspondent Contact Paul Dunleavy
Regulation Number878.4400
Classification Product Code
GEI  
Date Received07/29/2020
Decision Date 04/06/2022
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
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