# K221336: Avéli

- Pathway: 510(k) (Traditional)
- Applicant: Revelle Aesthetics, Inc.
- Decided: Aug 5, 2022 after 88 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: 7 generations back to DEN110004 (2013). 7 ancestors in all.
1 later device descends 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)
- K212399: Aveli, Nc8, Inc. (2021) Summary page 4.

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

## Indications for use
Avéli is indicated for long-term reduction in the appearance of cellulite in the buttocks and thigh areas of adult females as supported by clinical data demonstrating treatment benefits through one year of observation.

Source page: https://510kreport.com/device/K221336
Methodology: https://510kreport.com/methodology