Class Class II
AuroLase® System (K243701)
Description
AuroLase® System by Nanospectra Biosciences, Inc., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243701
Clearance Date2025-07-02
Clearance TypeTraditional
Product CodeGEX
Regulation Number878.4810
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243701
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. AuroLase® System (K243701) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K051996 | DIOMED DELTA 15, MODEL DELTA 15; DIOMED DELTA 30, MODEL DEL... | Diomed, Ltd. | 2005 |
Trace the full predicate network for K243701
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.