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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 K200468
Device Name V30 system, V20 system, V10 system, V-FC Handpiece
Applicant
Viora , Ltd.
6 Hagavish St.
Neanya,  IL 4250706
Applicant Contact Simona Forman Krant
Correspondent
Viora , Ltd.
6 Hagavish St.
Neanya,  IL 4250706
Correspondent Contact Simona Forman Krant
Regulation Number878.4400
Classification Product Code
PBX  
Subsequent Product Codes
GEX   ISA  
Date Received02/26/2020
Decision Date 05/21/2020
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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