510(k) · Cleared
ClearedSilhouette Instalift
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Silhouette Lift, Inc. · GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Cleared on Apr 24, 2015 after a 268-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 7 later devices descend from it.
- Decided
- Apr 24, 2015
- Review
- 268 days
- Class
- Class II
- Product code
- GAM
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK142061 Silhouette InstaliftSilhouette Lift, Inc. · 2015
- Descendant · cites it directly · 6 of its ownK163676 Silhouette InstaLiftSilhouette Lift, Inc. · 2017
- Descendant · 2 generations on · 4 of its ownK192423 MINT Product FamilyHans Biomed Corporation · 2020
- Descendant · 3 generations on · 2 of its ownK220549 MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures)…Hans Biomed Corporation · 2023
- Descendant · 4 generations on · 1 of its ownK240389 Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 )…Hyundae Meditech Co., Ltd. · 2024
- Descendant · 3 generations on · 0 of its ownK252171 Barbed PDO SutureSutura Medical Technology, Inc. · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K163676Silhouette InstaLiftSilhouette Lift, Inc. · 2017 · cites it directly6descendants
- K192423MINT Product FamilyHans Biomed Corporation · 2020 · 2 generations on4descendants
- K220549MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043…Hans Biomed Corporation · 2023 · 3 generations on2descendants
- K240389Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ); i-Thread…Hyundae Meditech Co., Ltd. · 2024 · 4 generations on1descendant
- K252171Barbed PDO SutureSutura Medical Technology, Inc. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K142061 | Silhouette Instalift | Silhouette Lift, Inc. | 2015 | — |
| +1 | K163676 | Silhouette InstaLift | Silhouette Lift, Inc. | 2017 | — |
| +2 | K192423 | MINT Product Family | Hans Biomed Corporation | 2020 | — |
| +3 | K220549 | MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift… | Hans Biomed Corporation | 2023 | — |
| +4 | K240389 | Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ); i-Thread… | Hyundae Meditech Co., Ltd. | 2024 | — |
| +3 | K252171 | Barbed PDO Suture | Sutura Medical Technology, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GAM? 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 GAM device
- #1 K252743 STRATAFIX™ Spiral PDS™ Plus Knotless Tissue…score 14.8 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K163676 (Silhouette Lift, Inc., 2017) has gone furthest, with 6 descendants of its own.
How does its category compare?
All GAM devicesGAM Suture, Absorbable, Synthetic, Polyglycolic Acid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · GAM
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GAM
29in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAM
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAM
8,970in 2025
MAUDE reports naming product code GAM, 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 | 7 | 50 | 10 | 274 |
| 2008 | 6 | 174 | 1 | 194 |
| 2009 | 3 | 10 | 6 | 287 |
| 2010 | 1 | — | 3 | 587 |
| 2011 | 2 | — | 6 | 637 |
| 2012 | 5 | 31 | 0 | 868 |
| 2013 | 1 | — | 0 | 898 |
| 2014 | 10 | 121 | 0 | 1,410 |
| 2015 | 5 | 209 | 0 | 935 |
| 2016 | 3 | 169 | 1 | 1,112 |
| 2017 | 8 | 134 | 1 | 1,499 |
| 2018 | 5 | 98 | 0 | 2,229 |
| 2019 | 4 | 90 | 1 | 3,564 |
| 2020 | 3 | 140 | 44 | 3,415 |
| 2021 | 2 | — | 0 | 4,506 |
| 2022 | 2 | — | 4 | 4,814 |
| 2023 | 1 | — | 0 | 5,070 |
| 2024 | 2 | — | 1 | 7,226 |
| 2025 | 3 | 29 | 0 | 8,970 |
| 2026 | 4 | 131 | 2 | — |
What is it indicated for?
The Silhouette Instalift device is indicated for use in mid-face suspension surgery to fixate the cheek sub dermis in an elevated position.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K142061 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142061: Silhouette Instalift.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142061
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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