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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 K232301
Device Name Define RF Microneedling System
Applicant
Aesthetic Management Partners
9019 Macon Rd.
Cordova,  TN  38016
Applicant Contact Shlomo Assa
Correspondent
Aesthetic Management Partners
9019 Macon Rd.
Cordova,  TN  38016
Correspondent Contact Shlomo Assa
Regulation Number878.4400
Classification Product Code
GEI  
Date Received08/01/2023
Decision Date 03/14/2024
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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