Class Class II

Vybe RF II (K241535)

K241535 2024-09-25 Traditional
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Description

Vybe RF II by ShenB Co., Ltd., an FDA 510(k) cleared general, plastic surgery device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK241535
Clearance Date2024-09-25
Clearance TypeTraditional
Product CodeGEI
Regulation Number878.4400

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Predicate lineage for K241535

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Vybe RF II (K241535) cites 2 predicate devices and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K230986Bladder ScannerAvantsonic Technology Co., Ltd.2023
K211562Virtue RFShenB Co., Ltd.2021

Trace the full predicate network for K241535

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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