# K052953: Nuvance* Facial Rejuvenation System

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Mar 6, 2006 after 137 days
- Product code: MXW (Suture, Surgical, Nonabsorbable, Poly (Vinylidene Fluoride))
- Device class: 2
- Regulation: 21 CFR 878.5010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) PRONOVA Suture: named in the summary without a submission number
- (no number) ENDOTINE Midface Device: named in the summary without a submission number
- (no number) FEATHERLUFT Threads: named in the summary without a submission number
- (no number) CONTOUR Threads: named in the summary without a submission number

## Indications for use
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.

Source page: https://510kreport.com/device/K052953
Methodology: https://510kreport.com/methodology