510(k) · Cleared
ClearedAvéli
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Revelle Aesthetics, Inc. · OUP Powered Surgical Instrument For Improvement In The Appearance Of Cellulite
Cleared on Aug 18, 2023 as substantially equivalent to K221336 (Revelle Aesthetics, Inc., 2022) and 1 other predicate after a 30-day review. Its family tree reaches back 8 generations to 2013.
- Decided
- Aug 18, 2023
- Review
- 30 days
- Class
- Class II
- Product code
- OUP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to DEN110004 (2013). 11 ancestors in all, the oldest K961122 (1996). No later device cites it as a predicate yet.
- Root · 8 generations backDEN110004 Cabochon SystemCabochon Aesthetics, Inc. · 2013
- 7 generations backK134010 Cabochon SystemCabochon Aesthetics, Inc. · 2014
- 6 generations backK150505 Cellfina SystemUlthera, Inc. · 2015
- 5 generations backK153677 The Cellfina SystemUlthera, Inc. · 2016
- 4 generations backK161885 The Cellfina SystemUlthera, Inc. · 2016 · Recalled
- 3 generations backK192185 The Cellfina SystemUlthera, Inc. · 2019
- 2 generations backK212399 AveliNc8, Inc. · 2021
- 1 generation backK221336 AvéliRevelle Aesthetics, Inc. · 2022
- This deviceK232153 AvéliRevelle Aesthetics, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | DEN110004 | Cabochon System | Cabochon Aesthetics, Inc. | 2013 | — |
| −7 | K134010 | Cabochon System | Cabochon Aesthetics, Inc. | 2014 | — |
| −6 | K150505 | Cellfina System | Ulthera, Inc. | 2015 | — |
| −5 | K153677 | The Cellfina System | Ulthera, Inc. | 2016 | — |
| −4 | K161885 | The Cellfina System | Ulthera, Inc. | 2016 | 1 |
| −3 | K192185 | The Cellfina System | Ulthera, Inc. | 2019 | — |
| −2 | K212399 | Aveli | Nc8, Inc. | 2021 | — |
| −1 | K221336 | Avéli | Revelle Aesthetics, Inc. | 2022 | — |
| 0 (this device) | K232153 | Avéli | Revelle Aesthetics, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2004 | 1 | 0 |
| 2011 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OUP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OUP device
- #1 K221336 Avéliscore 8.6 · 7 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K221336 | AvéliSummary page 5…Cellulite Release Device 3 Legally Market Predicate Devices Predicate # Predicate Trade Name Product Code K221336 Avéli OUP K111020 AtriCure Dissector GDI, FTD 4… | 2022 |
| * | K111020 | Atricure DissectorSummary page 5…edicate Devices Predicate # Predicate Trade Name Product Code K221336 Avéli OUP K111020 AtriCure Dissector GDI, FTD 4 Device Description Summary Avéli is a sterile, single-use manual… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 1.0 years on median.
- 1 of the 11 ancestors has a recall of any class.
How does its category compare?
All OUP devicesOUP Powered Surgical Instrument For Improvement In The Appearance Of Cellulite: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · OUP
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · OUP
Too few OUP 510(k)s in any year since 2007 to give a median.
Recalls per year · OUP
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OUP
4in 2025
MAUDE reports naming product code OUP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 2 | — | 1 | 3 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 0 | — | 0 | 8 |
| 2019 | 1 | — | 0 | 16 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 1 | — | 0 | 9 |
| 2022 | 1 | — | 0 | 15 |
| 2023 | 1 | — | 0 | 11 |
| 2024 | 0 | — | 0 | 6 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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. Avéli is also indicated for soft tissue dissection during general and plastic surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232153 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232153: Avéli.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232153
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026