LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001) (K230124)
Description
LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001) by Light Tree Ventures Europe B.V., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
FDA Database
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Predicate lineage for K230124
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. LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001) (K230124) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K214103 | Shani Darden LED light therapy mask | Harpar Grace International | 2022 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K230042 | Q-Rejuvalight Pro Facewear (Model: P19-0023) | Light Tree Ventures Europe B.V. | 2023 |
Trace the full predicate network for K230124
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.