510(k) · Cleared
ClearedCellfina System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ulthera, Inc. · OUP Powered Surgical Instrument For Improvement In The Appearance Of Cellulite
Cleared on Jul 29, 2015 as substantially equivalent to K134010 (Cabochon Aesthetics, Inc., 2014) after a 154-day review. Its family tree reaches back 2 generations to 2013. 6 later devices descend from it.
- Decided
- Jul 29, 2015
- Review
- 154 days
- Class
- Class II
- Product code
- OUP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN110004 (2013). 6 later devices descend from it, 1 citing it directly.
- Root · 2 generations backDEN110004 Cabochon SystemCabochon Aesthetics, Inc. · 2013
- 1 generation backK134010 Cabochon SystemCabochon Aesthetics, Inc. · 2014
- This deviceK150505 Cellfina SystemUlthera, Inc. · 2015
- Descendant · cites it directly · 5 of its ownK153677 The Cellfina SystemUlthera, Inc. · 2016
- Descendant · 2 generations on · 4 of its ownK161885 The Cellfina SystemUlthera, Inc. · 2016 · Recalled
- Descendant · 3 generations on · 3 of its ownK192185 The Cellfina SystemUlthera, Inc. · 2019
- Descendant · 4 generations on · 2 of its ownK212399 AveliNc8, Inc. · 2021
- Descendant · 5 generations on · 1 of its ownK221336 AvéliRevelle Aesthetics, Inc. · 2022
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K153677The Cellfina SystemUlthera, Inc. · 2016 · cites it directly5descendants
- K161885The Cellfina SystemUlthera, Inc. · 2016 · 2 generations on4descendants
- K192185The Cellfina SystemUlthera, Inc. · 2019 · 3 generations on3descendants
- K212399AveliNc8, Inc. · 2021 · 4 generations on2descendants
- K221336AvéliRevelle Aesthetics, Inc. · 2022 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN110004 | Cabochon System | Cabochon Aesthetics, Inc. | 2013 | — |
| −1 | K134010 | Cabochon System | Cabochon Aesthetics, Inc. | 2014 | — |
| 0 (this device) | K150505 | Cellfina System | Ulthera, Inc. | 2015 | — |
| +1 | K153677 | The Cellfina System | Ulthera, Inc. | 2016 | — |
| +2 | K161885 | The Cellfina System | Ulthera, Inc. | 2016 | 1 |
| +3 | K192185 | The Cellfina System | Ulthera, Inc. | 2019 | — |
| +4 | K212399 | Aveli | Nc8, Inc. | 2021 | — |
| +5 | K221336 | Avéli | Revelle Aesthetics, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K134010 | Cabochon SystemSummary page 4…Code: OUP LegallyMarketedPredicate: CellfinaSystem (tradenamepreviouslyCabochonSystem), 510(k): K134010 ApplicableGuidance: The following guidance special controls are applicable to the Cellfina… | 2014 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153677 | The Cellfina System | 2016 | 5 |
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 2 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K153677 (Ulthera, Inc., 2016) has gone furthest, with 5 descendants of its own.
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. 2015, 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?
The Cellfina™ System is intended for long term improvement in the appearance of cellulite in the buttocks and thigh areas of adult females as supported by clinical data demonstrating no significant reduction in treatment benefits up to 2 years of observation.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K150505 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150505: Cellfina System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150505
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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