Cleared Special

K171005 - Silhouette Featherlift

K171005 is the FDA 510(k) clearance for Silhouette Featherlift by Silhouette Lift, Inc.. It is a Class 2 General & Plastic Surgery device (product code GAW) cleared through the Special 510(k) pathway after a 29-day FDA review.

K171005 · Silhouette Lift, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2017
Decision
29d
Days
Class 2
Risk

K171005 is an FDA 510(k) clearance for the Silhouette Featherlift. Classified as Suture, Nonabsorbable, Synthetic, Polypropylene (product code GAW), Class II - Special Controls.

Submitted by Silhouette Lift, Inc. (Irvine, US). The FDA issued a Cleared decision on May 3, 2017 after a review of 29 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5010 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Silhouette Lift, Inc. devices

Submission Details

510(k) Number K171005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2017
Decision Date May 03, 2017
Days to Decision 29 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 115d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GAW Suture, Nonabsorbable, Synthetic, Polypropylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5010
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GAW Suture, Nonabsorbable, Synthetic, Polypropylene

All 26
Devices cleared under the same product code (GAW) and FDA review panel - the closest regulatory comparables to K171005.
REXLENE
K173747 · Sm Eng Co., Ltd. · Dec 2018
Aesculap Optilene Nonabsorbable Suture
K180321 · Aesculap, Inc. · Mar 2018
Gazelle Polypropylene Suture and Delivery Device
K173644 · Dura Tap, LLC · Feb 2018
EDWARDS LIFESCIENCES THRUPORT KNOTTING SYSTEM
K141206 · Edwards Lifesciences, LLC · Jan 2015
AESCULAP OPTILENE NONABSORBABLE SUTURE
K133890 · Aesculap, Inc. · Jul 2014
PROLENE POLYPROPYLENE NONABSORBABLE SUTURE
K133356 · Ethicon, Inc. · Dec 2013