De Novo · Granted
GrantedCabochon System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cabochon Aesthetics, Inc. · OUP Powered Surgical Instrument For Improvement In The Appearance Of Cellulite
Granted on Jul 12, 2013 as a new device type through De Novo after a 620-day review. 8 later devices descend from it.
- Decided
- Jul 12, 2013
- Review
- 620 days
- Class
- Class II
- Product code
- OUP
- Recalls
- None
8 later devices descend from it, 1 citing it directly.
- This deviceDEN110004 Cabochon SystemCabochon Aesthetics, Inc. · 2013
- Descendant · cites it directly · 7 of its ownK134010 Cabochon SystemCabochon Aesthetics, Inc. · 2014
- Descendant · 2 generations on · 6 of its ownK150505 Cellfina SystemUlthera, Inc. · 2015
- Descendant · 3 generations on · 5 of its ownK153677 The Cellfina SystemUlthera, Inc. · 2016
- Descendant · 4 generations on · 4 of its ownK161885 The Cellfina SystemUlthera, Inc. · 2016 · Recalled
- Descendant · 5 generations on · 3 of its ownK192185 The Cellfina SystemUlthera, Inc. · 2019
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K134010Cabochon SystemCabochon Aesthetics, Inc. · 2014 · cites it directly7descendants
- K150505Cellfina SystemUlthera, Inc. · 2015 · 2 generations on6descendants
- K153677The Cellfina SystemUlthera, Inc. · 2016 · 3 generations on5descendants
- K161885The Cellfina SystemUlthera, Inc. · 2016 · 4 generations on4descendants
- K192185The Cellfina SystemUlthera, Inc. · 2019 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN110004 | Cabochon System | Cabochon Aesthetics, Inc. | 2013 | — |
| +1 | K134010 | Cabochon System | Cabochon Aesthetics, Inc. | 2014 | — |
| +2 | K150505 | Cellfina System | Ulthera, Inc. | 2015 | — |
| +3 | K153677 | The Cellfina System | Ulthera, Inc. | 2016 | — |
| +4 | K161885 | The Cellfina System | Ulthera, Inc. | 2016 | 1 |
| +5 | K192185 | The Cellfina System | Ulthera, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA De Novo database (decision fields), 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K134010 | Cabochon System | 2014 | 7 |
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?
- Of its descendants, K134010 (Cabochon Aesthetics, Inc., 2014) has gone furthest, with 7 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. 2013, 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 | — |
https://510kreport.com/device/DEN110004 · printed Nov 4, 2026
Cite this page
510(k) Report. “DEN110004: Cabochon System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/DEN110004
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026