Class Class II
Cold Sore Device (QPZ-03) (K241155)
Description
Cold Sore Device (QPZ-03) by Shenzhen Nuon Medical Equipment Co., Ltd., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241155
Clearance Date2024-09-05
Clearance TypeTraditional
Product CodeOKJ
Regulation Number878.4860
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241155
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. Cold Sore Device (QPZ-03) (K241155) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K222205 | Cold Sore Device (Model: QPZ-01) | Light Tree Ventures Europe B.V. | 2022 |
Trace the full predicate network for K241155
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.