V30 System, V-Form Handpiece BC Medium Applicator

Powered Laser Surgical Instrument

Viora Ltd.

The following data is part of a premarket notification filed by Viora Ltd. with the FDA for V30 System, V-form Handpiece Bc Medium Applicator.

Pre-market Notification Details

Device IDK162363
510k NumberK162363
Device Name:V30 System, V-Form Handpiece BC Medium Applicator
ClassificationPowered Laser Surgical Instrument
Applicant Viora Ltd. 6 Hagavish Street Netanya,  IL 4250706
ContactStella Raizelman Perry
CorrespondentStella Raizelman Perry
Viora Ltd. 6 Hagavish Street Netanya,  IL 4250706
Product CodeGEX  
Subsequent Product CodeISA
Subsequent Product CodePBX
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-08-23
Decision Date2016-11-18
Summary:summary

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