Class Class II

Verifine® Ease Lancing Device, Verifine® Lancing Device (K223643)

K223643 2023-02-21 Traditional
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Description

Verifine® Ease Lancing Device, Verifine® Lancing Device by Promisemed Hangzhou Meditech Co., Ltd., an FDA 510(k) cleared general, plastic surgery device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK223643
Clearance Date2023-02-21
Clearance TypeTraditional
Product CodeQRL
Regulation Number878.4850

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Predicate lineage for K223643

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. Verifine® Ease Lancing Device, Verifine® Lancing Device (K223643) cites 1 predicate device and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K153670Genteel Lancing DeviceGenteel, LLC2016

Trace the full predicate network for K223643

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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