510(k) · Cleared
Recalled · Class II · 2016The Cellfina 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 Oct 5, 2016 as substantially equivalent to K153677 (Ulthera, Inc., 2016) after an 86-day review. Its family tree reaches back 4 generations to 2013. 4 later devices descend from it. It has been recalled once.
- Decided
- Oct 5, 2016
- Review
- 86 days
- Class
- Class II
- Product code
- OUP
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN110004 (2013). 4 later devices descend from it, 1 citing it directly.
- Root · 4 generations backDEN110004 Cabochon SystemCabochon Aesthetics, Inc. · 2013
- 3 generations backK134010 Cabochon SystemCabochon Aesthetics, Inc. · 2014
- 2 generations backK150505 Cellfina SystemUlthera, Inc. · 2015
- 1 generation backK153677 The Cellfina SystemUlthera, Inc. · 2016
- This deviceK161885 The Cellfina SystemUlthera, Inc. · 2016
- Descendant · cites it directly · 3 of its ownK192185 The Cellfina SystemUlthera, Inc. · 2019
- Descendant · 2 generations on · 2 of its ownK212399 AveliNc8, Inc. · 2021
- Descendant · 3 generations on · 1 of its ownK221336 AvéliRevelle Aesthetics, Inc. · 2022
- Descendant · 4 generations on · 0 of its ownK232153 AvéliRevelle Aesthetics, Inc. · 2023
Most influential descendants
Showing 4 of 4 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN110004 | Cabochon System | Cabochon Aesthetics, Inc. | 2013 | — |
| −3 | K134010 | Cabochon System | Cabochon Aesthetics, Inc. | 2014 | — |
| −2 | K150505 | Cellfina System | Ulthera, Inc. | 2015 | — |
| −1 | K153677 | The Cellfina System | Ulthera, Inc. | 2016 | — |
| 0 (this device) | K161885 | The Cellfina System | Ulthera, Inc. | 2016 | — |
| +1 | K192185 | The Cellfina System | Ulthera, Inc. | 2019 | — |
| +2 | K212399 | Aveli | Nc8, Inc. | 2021 | — |
| +3 | K221336 | Avéli | Revelle Aesthetics, Inc. | 2022 | — |
| +4 | K232153 | Avéli | Revelle Aesthetics, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K153677 | The Cellfina SystemSummary page 4…of cellulite. Regulation Number: 21CFR 878.4790 Product Code: OUP Legally Marketed Predicate: The Cellfina System, 510(k): K153677 Applicable Guidance: The following guidance special controls are applicable to the Cellfi… | 2016 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192185 | The Cellfina System | 2019 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 14, 2016 | Class II | Z-0749-2017 | Other | It was discovered that a non-sterile vacuum tube is supplied within the pack, although the Instructions for Use (IFU) describe the use of a sterile vacuum tube as part of the procedure setup. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 9 months on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K192185 (Ulthera, Inc., 2019) has gone furthest, with 3 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. 2016, 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 3 years of observation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161885 · printed Nov 5, 2026
Cite this page
510(k) Report. “K161885: The Cellfina System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161885
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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