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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Vacuum, Radio Frequency Induced Heat
510(k) Number K242553
Device Name MIRARI® Cold Plasma System ( GV-M2-01)
Applicant
General Vibronics, Inc.
1615 E. Warner Rd.
Suite #4
Tempe,  AZ  85284
Applicant Contact Huan Truong
Correspondent
General Vibronics, Inc.
1615 E. Warner Rd.
Suite #4
Tempe,  AZ  85284
Correspondent Contact Huan Truong
Regulation Number878.4400
Classification Product Code
PBX  
Subsequent Product Code
GEI  
Date Received08/27/2024
Decision Date 11/21/2024
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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