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

FDA 510(k)

Class II (US FDA 510(k))

510(k) K202247

by Viora Ltd

Identifiers

510(k) Number
K202247 FDA 510(k)
FDA Product Code
PBX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4400 FDA 510(k)
Regulation Number
878.4400 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

V30 system, V20 system, V10 system, V-VR Hand piece by Viora Ltd — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Viora Ltd
FDA Applicant
Viora , Ltd.

Sources (1)

  • FDA 510(k) K202247 24 fields · synced Jun 18, 2026