Class Class II
Tanning Lamp (K221523)
Description
Tanning Lamp by Unilam Co., Ltd., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK221523
Clearance Date2023-02-15
Clearance TypeTraditional
Product CodeLEJ
Regulation Number878.4635
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221523
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. Tanning Lamp (K221523) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K151674 | Ultraviolet Sun Tanning Lamp | G.I.E.- Gesellschaft Fur Lichttechn... | 2015 |
Trace the full predicate network for K221523
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.