510(k) · Cleared
ClearedRefine Lift System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alure Medical, Inc. · FTL Mesh, Surgical, Polymeric
Cleared on May 11, 2009 as substantially equivalent to K080216 (S. Jackson, Inc., 2008) and 2 other predicates after a 203-day review. Its family tree reaches back 2 generations to 1999. 1 later device descends from it.
- Decided
- May 11, 2009
- Review
- 203 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K992189 (1999). 7 ancestors in all, the oldest K831723 (1983). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK992189 Gore-Tex Dualmesh BiomaterialW. L. Gore & Associates, Inc. · 1999
- 1 generation backK081069 Gore Infinit MeshW. L. Gore & Associates, Inc. · 2008
- This deviceK083102 Refine Lift SystemAlure Medical, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK092538 Refine Support System, Model 100.0100Alure Medical, Inc. · 2010
Most influential descendants
Showing 1 of 1 · See all- K092538Refine Support System, Model 100.0100Alure Medical, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K992189 | Gore-Tex Dualmesh Biomaterial | W. L. Gore & Associates, Inc. | 1999 | — |
| −1 | K081069 | Gore Infinit Mesh | W. L. Gore & Associates, Inc. | 2008 | — |
| 0 (this device) | K083102 | Refine Lift System | Alure Medical, Inc. | 2009 | — |
| +1 | K092538 | Refine Support System, Model 100.0100 | Alure Medical, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 2 | 0 |
| 1985 | 1 | 0 |
| 2000 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
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 FTL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FTL device
- #1 K220091 Poly-Tape/Infinity-Lock Soft Tissue…score 16.8 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K080216 | Supramesh ExtraSummary page 1…Mesh, Surgical, Polymeric, (21 CFR 878.3300, Product Code FTL) Predicate Device Information K080216 SupraMesh EXTRATM K081069 INF1NIT Mesh KOO1 122 ProleneTM Soft (polypropylene) Mesh Product Description The RefineTM Support Syst… | 2008 |
| * | K081069 | Gore Infinit MeshSummary page 1…Mesh, Surgical, Polymeric, (21 CFR 878.3300, Product Code FTL) Predicate Device Information K080216 SupraMesh EXTRATM K081069 INF1NIT Mesh KOO1 122 ProleneTM Soft (polypropylene) Mesh Product Description The RefineTM Support System consists of a non-absor… | 2008 |
| * | K001122 | Prolene Soft (Polypropylene), Nonabsorbabale Synthetic Surgical Mesh | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092538 | Refine Support System, Model 100.0100 | 2010 | 0 |
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.
What does this lineage say?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 8.8 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K092538 (Alure Medical, Inc., 2010) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · FTL
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTL
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTL
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTL
3,487in 2025
MAUDE reports naming product code FTL, 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 | 20 | 92 | 2 | 1,737 |
| 2008 | 23 | 114 | 1 | 1,569 |
| 2009 | 15 | 97 | 1 | 1,906 |
| 2010 | 18 | 132 | 12 | 2,175 |
| 2011 | 15 | 90 | 8 | 3,608 |
| 2012 | 12 | 213 | 2 | 14,700 |
| 2013 | 8 | 90 | 1 | 26,519 |
| 2014 | 11 | 70 | 3 | 2,683 |
| 2015 | 12 | 121 | 0 | 2,526 |
| 2016 | 3 | 186 | 0 | 2,417 |
| 2017 | 6 | 132 | 1 | 3,947 |
| 2018 | 12 | 105 | 1 | 11,893 |
| 2019 | 4 | 99 | 0 | 21,724 |
| 2020 | 5 | 138 | 1 | 18,819 |
| 2021 | 2 | — | 0 | 16,284 |
| 2022 | 6 | 195 | 0 | 11,439 |
| 2023 | 4 | 29 | 0 | 8,025 |
| 2024 | 2 | — | 0 | 8,565 |
| 2025 | 6 | 30 | 0 | 3,487 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The RefineTM Support System is indicated for reinforcement of soft tissue in plastic or reconstructive procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083102 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083102: Refine Lift System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083102
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026