FDA product code · General and plastic surgery
Implant, Dermal, For Aesthetic Use
22 FDA decisions since 1981. 3 recalls name this code, 0 of them Class I.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of LMH 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 · LMH
51in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LMH
Too few LMH 510(k)s in any year since 2007 to give a median.
Recalls per year · LMH
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LMH
1,805in 2025
MAUDE reports naming product code LMH, 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 | 15 | — | 0 | 175 |
| 2008 | 50 | — | 0 | 308 |
| 2009 | 37 | — | 0 | 1,217 |
| 2010 | 19 | — | 0 | 736 |
| 2011 | 21 | — | 2 | 449 |
| 2012 | 44 | — | 0 | 402 |
| 2013 | 39 | — | 0 | 451 |
| 2014 | 61 | — | 0 | 786 |
| 2015 | 60 | — | 1 | 885 |
| 2016 | 45 | — | 0 | 691 |
| 2017 | 52 | — | 0 | 1,509 |
| 2018 | 57 | — | 0 | 1,803 |
| 2019 | 68 | — | 0 | 1,273 |
| 2020 | 61 | — | 0 | 1,156 |
| 2021 | 51 | — | 0 | 1,422 |
| 2022 | 40 | — | 0 | 1,358 |
| 2023 | 81 | — | 0 | 1,478 |
| 2024 | 74 | — | 0 | 1,372 |
| 2025 | 51 | — | 0 | 1,805 |
| 2026 | 56 | — | 0 | — |
Planning a device in LMH? 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