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Silhouette Featherlift

by Silhouette Lift, Inc.

510(k) K191299

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK191299 Date14 Jun 2019ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Silhouette Featherlift / Silhouette Lift
510(k) Number
FDA Product Code
GAW
Device Class
Class II
Regulation
21 CFR Part 878.5010
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Silhouette Featherlift is a suture, nonabsorbable, synthetic, polypropylene device designed for midface suspension procedures. It is intended to fixate the cheek subdermis in an elevated position, providing structural support to the facial tissues.

This device is supplied as a sterile, single-use suture system and is classified as Class II under FDA regulations (21 CFR 878.5010). It is intended for use in surgical settings by qualified healthcare professionals. The device is cleared through an FDA 510(k) pathway (K191299) and is not MRI-compatible. Available in multiple reference codes, it requires proper storage to maintain sterility and integrity.

Other devices from Silhouette Lift, Inc.

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Silhouette Featherlift primarily used for in surgical procedures?

    The Silhouette Featherlift is designed for midface suspension procedures, specifically to fixate the cheek subdermis in an elevated position. This provides structural support to the facial tissues, helping to maintain a lifted appearance during and after surgery.

  • Is the Silhouette Featherlift intended for reuse or is it single-use only?

    The Silhouette Featherlift is supplied as a sterile, single-use suture system. It is not intended for reuse, and proper storage must be maintained to preserve its sterility and integrity for one-time surgical use.

  • How many different reference codes or models are available for the Silhouette Featherlift?

    The Silhouette Featherlift is available in multiple reference codes, with over 60 distinct FEI numbers listed in regulatory records. These variations may correspond to different sizes, lengths, or configurations for surgical flexibility.

  • What storage conditions are required to maintain the device’s sterility and performance?

    The Silhouette Featherlift must be stored under conditions that preserve its sterility and integrity. Since it is a single-use, sterile suture system, it should be kept in its original packaging, protected from contamination, moisture, and extreme temperatures until use.

  • Can the Silhouette Featherlift be used in an MRI environment, or is it MRI-compatible?

    The Silhouette Featherlift is not MRI-compatible. This means it should not be used in patients who require MRI imaging, as the device could interfere with the scan or pose risks during the procedure.