PMA · Approved
ApprovedJuvéderm Voluma XC, Juvéderm Vollure XC, Juvéderm Volbella XC, Juvéderm Volux XC and SKINVIVE by Juvéderm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Allergan · LMH Implant, Dermal, For Aesthetic Use
Approved on Aug 28, 2026 through premarket approval, which rests on the device’s own clinical evidence after a 29-day review.
- Decided
- Aug 28, 2026
- Review
- 29 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.
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. 2026, this device’s year, is highlighted.
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/P110033/S102 · printed Nov 6, 2026
Cite this page
510(k) Report. “P110033/S102: Juvéderm Voluma XC, Juvéderm Vollure XC, Juvéderm Volbella XC, Juvéderm Volux XC and SKINVIVE by Juvéderm.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P110033/S102
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded Oct 30, 2026
- Page last updated Nov 3, 2026