510(k) Report

510(k) · Cleared

Cleared

Silhouette InstaLift

K163676510(k) TraditionalCleared Jun 16, 2017171-day reviewClass II21 CFR 878.4493

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Silhouette Lift, Inc. · GAM Suture, Absorbable, Synthetic, Polyglycolic Acid

Cleared on Jun 16, 2017 as substantially equivalent to K142061 (Silhouette Lift, Inc., 2015) after a 171-day review. Its family tree reaches back 1 generation to 2015. 6 later devices descend from it.

Decided
Jun 16, 2017
Review
171 days
Class
Class II
Product code
GAM
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K142061 (2015). 6 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2020: 2 descendants cleared2023: 1 descendant cleared2026: 1 descendant cleared2024: 2 descendants clearedK142061 · Silhouette Instalift · Silhouette Lift, Inc. · 2015201620182020202220242026
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 1 descendant4 generations forward: 1 descendant K142061 · Silhouette Instalift · Silhouette Lift, Inc. · 20150
  1. Root · 1 generation backK142061 Silhouette InstaliftSilhouette Lift, Inc. · 2015
  2. This deviceK163676 Silhouette InstaLiftSilhouette Lift, Inc. · 2017
  3. Descendant · cites it directly · 4 of its ownK192423 MINT Product FamilyHans Biomed Corporation · 2020
  4. Descendant · 2 generations on · 2 of its ownK220549 MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures)…Hans Biomed Corporation · 2023
  5. Descendant · 3 generations on · 1 of its ownK240389 Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 )…Hyundae Meditech Co., Ltd. · 2024
  6. Descendant · 2 generations on · 0 of its ownK252171 Barbed PDO SutureSutura Medical Technology, Inc. · 2026
  7. Descendant · 4 generations on · 0 of its ownK242571 Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150…Hyundae Meditech Co., Ltd. · 2024

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2020: 22023: 12024: 22026: 1
2020high 2 (2020) · low 0 (2021)2026

Most influential descendants

Showing 5 of 6 · See all
  • K192423MINT Product FamilyHans Biomed Corporation · 2020 · cites it directly4descendants
  • K220549MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043…Hans Biomed Corporation · 2023 · 2 generations on2descendants
  • K240389Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ); i-Thread…Hyundae Meditech Co., Ltd. · 2024 · 3 generations on1descendant
  • K252171Barbed PDO SutureSutura Medical Technology, Inc. · 2026 · 2 generations on0descendants
  • K242571Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150 FC19100E150…Hyundae Meditech Co., Ltd. · 2024 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K142061Silhouette InstaliftSilhouette Lift, Inc.2015—
0 (this device)K163676Silhouette InstaLiftSilhouette Lift, Inc.2017—
+1K192423MINT Product FamilyHans Biomed Corporation2020—
+2K220549MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift…Hans Biomed Corporation2023—
+3K240389Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ); i-Thread…Hyundae Meditech Co., Ltd.2024—
+2K252171Barbed PDO SutureSutura Medical Technology, Inc.2026—
+4K242571Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150…Hyundae Meditech Co., Ltd.2024—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202020
202310
202420
202610
FIG. 1 — Lineage of K163676, 2015–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 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. #1 K252743 STRATAFIX™ Spiral PDS™ Plus Knotless Tissue…score 14.8 · 15 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K142061Silhouette Instalift
Summary page 4
…Product Code: GAM Device Classification: II Predicate Device: The predicate is the original Silhouette Instalift device cleared under 510(k) number K142061 on April 24, 2015. Device Description: The Silhouette Instalift device consists of two Stainless Steel Surgical needles and an a…
Silhouette Lift, Inc.2015—

Also cleared against K142061: 1 other device →

What descends from it? (6)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K192423MINT Product FamilyHans Biomed Corporation20204
K200140Silhouette InstaliftSilhouette Lift, Inc.20200

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?

  • Its one ancestor has no recall.
  • Of its descendants, K192423 (Hans Biomed Corporation, 2020) has gone furthest, with 4 descendants of its own.
  • 1 other device also cites its predicate K142061.

How does its category compare?

All GAM devices

GAM Suture, Absorbable, Synthetic, Polyglycolic Acid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · GAM

3in 2025

2007: 72008: 62009: 32010: 12011: 22012: 52013: 12014: 102015: 52016: 32017: 82018: 52019: 42020: 32021: 22022: 22023: 12024: 22025: 32026 (partial year): 4
2007high 10 (2014) · low 1 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GAM

29in 2025

2007: 50 days median2008: 174 days median2009: 10 days median2012: 31 days median2014: 121 days median2015: 209 days median2016: 169 days median2017: 134 days median2018: 98 days median2019: 90 days median2020: 140 days median2025: 29 days median2026 (partial year): 131 days median
2007high 209 (2015) · low 10 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GAM

1in 2024

2007: 102008: 12009: 62010: 32011: 62016: 12017: 12019: 12020: 442022: 42024: 12026 (partial year): 2
2007high 44 (2020) · low 0 (2012)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GAM

8,970in 2025

2007: 2742008: 1942009: 2872010: 5872011: 6372012: 8682013: 8982014: 1,4102015: 9352016: 1,1122017: 1,4992018: 2,2292019: 3,5642020: 3,4152021: 4,5062022: 4,8142023: 5,0702024: 7,2262025: 8,970
2007high 8,970 (2025) · low 194 (2008)2025

MAUDE reports naming product code GAM, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200775010274
200861741194
20093106287
20101—3587
20112—6637
20125310868
20131—0898
20141012101,410
201552090935
2016316911,112
2017813411,499
201859802,229
201949013,564
20203140443,415
20212—04,506
20222—44,814
20231—05,070
20242—17,226
202532908,970
202641312—

What is it indicated for?

The Silhouette Instalift device is indicated for use in mid-face suspension surgery to temporarily fixate the cheek sub dermis in an elevated position.

Indications for use as stated in the FDA summary.

Also cleared against K142061

1 other device cites the same predicate.

  • K200140Silhouette InstaliftSilhouette Lift, Inc. · 2020

More from Silhouette Lift, Inc.

5 FDA decisions under this applicant name. See the company

  • K200140Silhouette InstaliftSilhouette Lift, Inc. · 2020
  • K191299Silhouette Featherlift / Silhouette LiftSilhouette Lift, Inc. · 2019
  • K171005Silhouette FeatherliftSilhouette Lift, Inc. · 2017
  • K142061Silhouette InstaliftSilhouette Lift, Inc. · 2015

Recent decisions in GAM

The GAM category page

  • K263073Fast Absorbing PGLARiverpoint Medical, LLC · 2026
  • K253394Coated VICRYL™ (Polyglactin 910) Plus Antibacterial SutureETHICON, Inc. · 2026
  • K253530Trexon™ Monofilament Synthetic Absorbable SutureMedtronic · 2026
  • K253852MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical SutureETHICON, Inc. · 2026
  • K252743STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue…ETHICON, Inc. · 2025

https://510kreport.com/device/K163676 · printed Nov 5, 2026

Cite this page

510(k) Report. “K163676: Silhouette InstaLift.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163676

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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