Cleared Special

Silhouette Featherlift

K171005 · Silhouette Lift, Inc. · General & Plastic Surgery
May 2017
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K171005 is an FDA 510(k) clearance for the Silhouette Featherlift, a Suture, Nonabsorbable, Synthetic, Polypropylene (Class II — Special Controls, product code GAW), submitted by Silhouette Lift, Inc. (Irvine, US). The FDA issued a Cleared decision on May 3, 2017, 29 days after receiving the submission on April 4, 2017. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5010.

Submission Details

510(k) Number K171005 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code GAW — Suture, Nonabsorbable, Synthetic, Polypropylene
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.5010