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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Low Power Electrosurgical Devices For Skin Lesion Destruction
510(k) Number K223440
Device Name Plasma Pen (Plasma MD); Plasma Pen (Plasma +)
Applicant
Plasma Concepts
800 W Cummings Park
Woburn,  MA  01801
Applicant Contact Brendan Aarons
Correspondent
Medicept, LLC
200 Homer Ave.,
Ashland,  MA  01721
Correspondent Contact Richelle Helman
Regulation Number878.4400
Classification Product Code
QVJ  
Date Received11/14/2022
Decision Date 03/02/2023
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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