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VYBE RF Electrosurgical System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K230968

by shenb Co., Ltd.

Identifiers

510(k) Number
K230968 FDA 510(k)
FDA Product Code
GEI 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)

The VYBE RF Electrosurgical System is an electrosurgical cutting and coagulation device and accessories. It is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis and the percutaneous treatment.

The device is supplied as a Class II medical device with FDA 510(k) clearance under product code GEI. It is manufactured by ShenB Co., Ltd. and was cleared on July 6, 2023, under K230968.

Frequently asked questions

What is the VYBE RF Electrosurgical System used for?

The VYBE RF Electrosurgical System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis, as well as percutaneous treatment, based on its cleared indications for cutting and coagulation in these clinical settings.

How is the VYBE RF Electrosurgical System supplied and what is its regulatory classification?

The device is supplied as a Class II medical device with FDA 510(k) clearance under product code GEI, indicating it was found substantially equivalent to a predicate device through the special 510(k) pathway, as confirmed by its authorization details.

Who manufactures the VYBE RF Electrosurgical System and when was it cleared?

The VYBE RF Electrosurgical System is manufactured by ShenB Co., Ltd. and received FDA 510(k) clearance on July 6, 2023, under submission number K230968, following its receipt on April 5, 2023.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: VYBE RF Electrosurgical System (K230968) — FDA 510 (k) | Innolitics, PDF ShenB Co. Ltd. - accessdata.fda.gov, K230968 - VYBE RF Electrosurgical System | FDA 510(k), VYBE RF Electrosurgical System 510 (k) K230968 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
shenb Co., Ltd.

Sources (1)

  • FDA 510(k) K230968 24 fields · synced Sep 24, 2026