FDA product code · General and plastic surgery
Powered Surgical Instrument For Improvement In The Appearance Of Cellulite
9 FDA decisions since 2013. 510(k) reviews decided 2021–2025 took a median of 81 days (half between 56 and 85). 1 recall names this code; it is not Class I. The most-cited predicate is K161885, named by 1 later device.
Used for controlled release of subcutaneous tissue for improvement in the appearance of cellulite.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of OUP at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.
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 | — |
Planning a device in OUP? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report