Class Class II
AVAVA™ Skin Treatment System (K250402)
Description
AVAVA™ Skin Treatment System by Avava, Inc., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250402
Clearance Date2025-04-14
Clearance TypeTraditional
Product CodeONG
Regulation Number878.4810
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250402
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. AVAVA™ Skin Treatment System (K250402) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K250540 | SABER-C System | Elevation Spine | 2025 |
| K223871 | Miria Skin Treatment System | AVAVA, Inc. | 2023 |
| K221268 | SR-1 Skin Treatment System | AVAVA, Inc. | 2022 |
Trace the full predicate network for K250402
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.