V30 System, V20 System, V10 System, V-FR Handpiece

Massager, Vacuum, Radio Frequency Induced Heat

Viora Ltd.

The following data is part of a premarket notification filed by Viora Ltd. with the FDA for V30 System, V20 System, V10 System, V-fr Handpiece.

Pre-market Notification Details

Device IDK201064
510k NumberK201064
Device Name:V30 System, V20 System, V10 System, V-FR Handpiece
ClassificationMassager, Vacuum, Radio Frequency Induced Heat
Applicant Viora Ltd. 6 Hagavish Street Neanya,  IL 4250706
ContactSimona F. Krant
CorrespondentSimona F. Krant
Viora Ltd. 6 Hagavish Street Neanya,  IL 4250706
Product CodePBX  
Subsequent Product CodeGEI
Subsequent Product CodeGEX
Subsequent Product CodeISA
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-21
Decision Date2020-07-15

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