# K092538: Refine Support System, Model 100.0100

- Pathway: 510(k) (Traditional)
- Applicant: Alure Medical, Inc.
- Decided: Mar 5, 2010 after 198 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K992189 (1999). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083102: Refine Lift System, Alure Medical, Inc. (2009) Summary page 1.

## Indications for use
The Refine TM Support System is indicated for reinforcement of soft tissue in plastic or reconstructive procedures.

Source page: https://510kreport.com/device/K092538
Methodology: https://510kreport.com/methodology