Enhanced AURORA™ Medical Diode System, and related accessories (K230076)
Description
Enhanced AURORA™ Medical Diode System, and related accessories by Psoria-Shield, Inc., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230076
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. Enhanced AURORA™ Medical Diode System, and related accessories (K230076) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K192411 | Psoria-Shield AURORA | Psoria-Shield | 2020 |
| K073659 | XTRAC ULTRA 2, MODEL AL10000 | Photo Medex, Inc. | 2008 |
Trace the full predicate network for K230076
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.