Class Class II
handLITE (TN19S) (K250224)
Description
handLITE (TN19S) by Ismart Developments, Ltd., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250224
Clearance Date2025-04-18
Clearance TypeTraditional
Product CodeONE
Regulation Number878.4810
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250224
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. handLITE (TN19S) (K250224) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K191629 | faceLITE | Ismart Marketing Svcs, Ltd. | 2019 |
| K171055 | Philips BlueControl | Philips Electronics Nederland B.V. | 2017 |
Trace the full predicate network for K250224
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.