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FDA 510(k)

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

K-Number: K201064 · 2020-07-15

ApplicantViora , Ltd.
Decision Date2020-07-15
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

V30 System, V20 System, V10 System, V-FR Handpiece is a medical device manufactured by Viora , Ltd.. It received FDA 510(k) clearance on 2020-07-15 under approval number K201064. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the V30 System, V20 System, V10 System, V-FR Handpiece?

V30 System, V20 System, V10 System, V-FR Handpiece is a medical device that received FDA 510(k) clearance on 2020-07-15. It is manufactured by Viora , Ltd.. The 510(k) number is K201064.

When was V30 System, V20 System, V10 System, V-FR Handpiece approved by the FDA?

V30 System, V20 System, V10 System, V-FR Handpiece received FDA 510(k) clearance on 2020-07-15, under approval number K201064.

What company makes V30 System, V20 System, V10 System, V-FR Handpiece?

V30 System, V20 System, V10 System, V-FR Handpiece is manufactured by Viora , Ltd..

What is the FDA product code for V30 System, V20 System, V10 System, V-FR Handpiece?

The FDA product code for V30 System, V20 System, V10 System, V-FR Handpiece is PBX.

Other Devices by Viora , Ltd.

K162363V30 system, V-Form Handpiece BC Medium applicator K152611V20 system K202247V30 system, V20 system, V10 system, V-VR Hand piece K200468V30 system, V20 system, V10 system, V-FC Handpiece

Related Devices (Code: PBX)

K162512truSculptCutera, Inc. K161458Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep CareIndiba USA, Inc. K161551TR-100BTL Industries, Inc. K161043Profound SystemSyneron Candela Corporation K160329InMode System MiniFX HandpieceInmode MD , Ltd. K161199EndyMed Contour HandpieceEndymed Medical, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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