510(k) · Cleared
ClearedNuvance* Facial Rejuvenation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ETHICON, Inc. · MXW Suture, Surgical, Nonabsorbable, Poly (Vinylidene Fluoride)
Cleared on Mar 6, 2006 after a 137-day review. The FDA summary names its predicate without a number.
- Decided
- Mar 6, 2006
- Review
- 137 days
- Class
- Class II
- Product code
- MXW
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 MXW? 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
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | — | PRONOVA Suture Named without a submission number | |
| * | — | ENDOTINE Midface Device Named without a submission number | |
| * | — | FEATHERLUFT Threads Named without a submission number | |
| * | — | CONTOUR Threads Named without a submission number |
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 MXW devicesMXW Suture, Surgical, Nonabsorbable, Poly (Vinylidene Fluoride): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MXW
1in 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · MXW
Too few MXW 510(k)s in any year since 2007 to give a median.
Recalls per year · MXW
No recall names MXW since 2007.
Adverse event reports per year · MXW
No MAUDE report names MXW since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
NUVANCE* Facial Rejuvenation System is intended to fixate subdermal tissue in an elevated position in plastic and reconstructive surgery. The device may be used in areas such as the forehead, midface, jowls and neck.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052953 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052953: Nuvance* Facial Rejuvenation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052953
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026