# K212399: Aveli

- Pathway: 510(k) (Traditional)
- Applicant: Nc8, Inc.
- Decided: Oct 22, 2021 after 81 days
- Product code: OUP (Powered Surgical Instrument For Improvement In The Appearance Of Cellulite)
- Device class: 2
- Regulation: 21 CFR 878.4790
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to DEN110004 (2013). 6 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192185: The Cellfina System, Ulthera, Inc. (2019) Summary page 4.

## Most influential descendants
- K221336: Avéli (2022), 1 descendant of its own
- K232153: Avéli (2023), 0 descendants of its own

## Indications for use
Avéli is indicated for temporary reduction in the appearance of cellulite in the buttocks and thigh areas of adult females as supported by clinical data demonstrating benefits through three months of observation.

Source page: https://510kreport.com/device/K212399
Methodology: https://510kreport.com/methodology