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FDA 510(k)

V30 system, V20 system, V10 system, V-VR Hand piece

K-Number: K202247 · 2020-12-09

ApplicantViora , Ltd.
Decision Date2020-12-09
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

V30 system, V20 system, V10 system, V-VR Hand piece is the device name listed in this FDA 510(k) record. The listed applicant is Viora , Ltd.. It received FDA 510(k) clearance on 2020-12-09 under 510(k) number K202247. 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-VR Hand piece?

V30 system, V20 system, V10 system, V-VR Hand piece is a medical device that received FDA 510(k) clearance on 2020-12-09. The listed applicant is Viora , Ltd.. The 510(k) number is K202247.

When did V30 system, V20 system, V10 system, V-VR Hand piece receive FDA 510(k) clearance?

V30 system, V20 system, V10 system, V-VR Hand piece received FDA 510(k) clearance on 2020-12-09, under 510(k) number K202247.

Who is the listed applicant for V30 system, V20 system, V10 system, V-VR Hand piece?

The FDA 510(k) record lists Viora , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for V30 system, V20 system, V10 system, V-VR Hand piece?

The FDA product code for V30 system, V20 system, V10 system, V-VR Hand piece is PBX.

Other records listing Viora , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K201064V30 System, V20 System, V10 System, V-FR HandpieceK200468V30 system, V20 system, V10 system, V-FC HandpieceK162363V30 system, V-Form Handpiece BC Medium applicatorK152611V20 system

Related Devices (Code: PBX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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