510(k) Report

FDA applicant

Silhouette Lift, Inc.

Irvine, CA5 decisions2015–20200 recalls

FDA records 5 decisions for Silhouette Lift, Inc. (Irvine, CA) from 2015 to 2020: 5 510(k) clearances. Most are in product codes GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid) and GAW (Suture, Nonabsorbable, Synthetic, Polypropylene). Since 2016 its 510(k)s took a median of 66 days from receipt to decision, against 140 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 4 of them its own earlier devices. No recall is linked to its devices.

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

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Silhouette Lift, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2015: 12017: 22019: 12020: 1
2015high 2 (2017) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Silhouette Lift, Inc. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Silhouette Lift, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • GAMSuture, Absorbable, Synthetic, Polyglycolic Acid3decisions
  • GAWSuture, Nonabsorbable, Synthetic, Polypropylene2decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 66 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 140 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 4 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K142061Silhouette InstaliftSilhouette Lift, Inc. · 20152cite it
  • K163676Silhouette InstaLiftSilhouette Lift, Inc. · 20172cite it
  • K171005Silhouette FeatherliftSilhouette Lift, Inc. · 20171cites it

What has FDA decided for it lately?

  • K200140Silhouette InstaliftSilhouette Lift, Inc. · 2020
  • K191299Silhouette Featherlift / Silhouette LiftSilhouette Lift, Inc. · 2019
  • K163676Silhouette InstaLiftSilhouette Lift, Inc. · 2017
  • K171005Silhouette FeatherliftSilhouette Lift, Inc. · 2017
  • K142061Silhouette InstaliftSilhouette Lift, Inc. · 2015

All 5 as Silhouette Lift, Inc. →

Other applicant names beginning “Silhouette”

FDA records each applicant name separately; these may or may not be the same firm.

Silhouette Optical, Ltd. 2