PMA · Approved
ApprovedSculptra and Sculptra Aesthetic
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Q-Med AB · LMH Implant, Dermal, For Aesthetic Use
Approved on Aug 3, 2004 through premarket approval, which rests on the device’s own clinical evidence after a 246-day review.
- Decided
- Aug 3, 2004
- Review
- 246 days
- Class
- Class III
- Product code
- LMH
- Recalls
- None
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P030050 has 54 supplements since 2005: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2005 | 1 |
| 2008 | 1 |
| 2009 | 3 |
| 2010 | 2 |
| 2011 | 3 |
| 2012 | 1 |
| 2013 | 4 |
| 2014 | 5 |
| 2015 | 1 |
| 2016 | 2 |
| 2017 | 2 |
| 2018 | 2 |
| 2020 | 3 |
| 2021 | 3 |
| 2022 | 3 |
| 2023 | 5 |
| 2024 | 10 |
| 2026 | 3 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LMH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
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.
How does its category compare?
All LMH devicesLMH Implant, Dermal, For Aesthetic Use: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/P030050 · printed Nov 6, 2026
Cite this page
510(k) Report. “P030050: Sculptra and Sculptra Aesthetic.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P030050
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026