Cleared Special

Silhouette Featherlift / Silhouette Lift

K191299 · Silhouette Lift, Inc. · General & Plastic Surgery
Jun 2019
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K191299 is an FDA 510(k) clearance for the Silhouette Featherlift / Silhouette Lift, 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 June 14, 2019, 31 days after receiving the submission on May 14, 2019. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5010.

Submission Details

510(k) Number K191299 FDA.gov
FDA Decision Cleared SESE
Date Received May 14, 2019
Decision Date June 14, 2019
Days to Decision 31 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